FY2011 Financial Supports for Promoting the “Sixth Industry” in Agriculture, Forestry and Fisheries and Rural Areas Creation and Promotion of the “Sixth Industry” for Pioneering the Future Overseas Business Support Project for Japanese Food Industry in East Asia “Investigation of Commodity Food Standards and Food Additives in Asia”(Ⅲ) August, 2012 International Life Sciences Institute(ILSI Japan)
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FY2011 Financial Supports for Promoting the “Sixth Industry” in Agriculture,
Forestry and Fisheries and Rural Areas
Creation and Promotion of the “Sixth Industry” for Pioneering the Future
Overseas Business Support Project for Japanese Food Industry in East Asia
“Investigation of Commodity Food Standards
and Food Additives in Asia”(Ⅲ)
August, 2012
International Life Sciences Institute(ILSI Japan)
Contents
1. Purpose of the Investigation ……………………………… 1
2. Outline of the Investigation ……………………………… 2
2.1 Countries covered by the Investigation …………… 3
2.2 Food(s) covered by the Investigation ……………… 3
2.3 Methods of the Investigation ……………………… 3
2.4 Project Team ……………………………… 4
2.5 Schedule of the Investigation ………………………… 5
3. The Investigation Results for Each Country
3.1 Codex ……………………………… 6
3.2 Japan ……………………………… 19
3.3 Korea ……………………………… 33
3.4 China ……………………………… 49
3.5 Southeast Asia ……………………………… 65
3.5.1 Malaysia ……………………………… 65
3.5.2 Singapore ……………………………… 79
3.5.3 Philippines ……………………………… 89
3.5.4 Indonesia ……………………………… 101
3.5.5 Thailand ……………………………… 115
3.5.6 Vietnam ……………………………… 131
3.6 Overall Report ……………………………… 145
4. India ……………………………… 151
5. Halal ……………………………… 161
6. International Conference ……………………………… 173
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FY2011 Financial Supports for Promoting the “Sixth Industry” in Agriculture,
Forestry and Fisheries and Rural Areas
Creation and Promotion of the “Sixth Industry” for Pioneering the Future
Overseas Business Support Project for Japanese Food Industry in East Asia
“Investigation of Commodity Food Standards
and Food Additives in Asia”(Ⅲ)
Reported by : Hiroaki Hamano, International Life Sciences Institute
Hiroshi Iwamoto (Morinaga Milk Industry Co., Ltd.)
Youichiro Umeki (Danisco Japan Co.)
Toshihisa Ohta (Yakult Honsha Co., Ltd.)
Hiromi Ohta (Suntory Wellness Ltd.)
Yoko Ogiwara (Ajinomoto Co., Inc. ASEAN Regional HQs)
Satoru Kasai (Nihon Kraft Foods Limited)
Kiyohisa Kaneko (Coca-Cola (Japan) Co., Ltd.)
Kaori Kusano (Kirin Group Office Company, Ltd.)
Yoshiharu Kuma (Kuma Consulting Engineer Office)
Masanori Kohmura (Ajinomoto Co., Inc.)
Yukio Suzuki (Schiff's Japan)
Fumiko Sekiya (Takasago International Co.)
Tomoko Takahashi (Nestle Japan Ltd.)
Hisahiro Tatewaki (Kirin Holdings Company, Ltd.)
Hidekazu Hosono (Suntory Business Expert Ltd.)
Kensuke Watanabe (Suntory Business Expert Ltd.)
Ryuji Yamaguchi (ILSI Japan)
Hisami Shinohara (ILSI Japan)
Shuji Iwata (ILSI Japan)
Kazuo Sueki (ILSI Japan)
ILSI Korea
ILSI Focal Point in China
ILSI Southeast Asia Region
1. Purpose of the Investigation
In order to strengthen management practices and international competitiveness of
Japanese food industry that is facing quantitative saturation and maturity in
domestic market, it is necessary to address developing business in East Asian
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regions where attractive market is forming due to increasing population and
dynamically growing economy.
In the past, Japanese food industry has been reluctant to develop new business in
East Asia due to lack of information and understanding on food standards, methods
of analysis, and conditions for use of food additives in the countries. The information
including consistency with international standards such as Codex Standards should
be compiled on database. Providing these information enable Japanese food industry
to start and promote new business or facilitate smooth business in East Asian
regions.
This investigation aimed to encourage Japanese food industry to enter into the East
Asian market and to enable to start new business there, by using results of the
investigation discussed at a workshop, training courses and/or individual consulting
sessions held in Japan or in such East Asian countries, and by disseminating those
results on the ILSI Japan website.
2. Outline of the Investigation
In order to expand distribution of foods and food materials in East Asian region
according to MAFF (Ministry of Agriculture, Forestry and Fisheries)'s "East Asian
Food Industry Revitalization Strategy", product standards, methods of analysis, and
conditions for use of food additives for foods and food materials are required to be
standardized or harmonized in the Region. This project intends to investigate the
product standards, methods of analysis, and conditions for use of food additives on
main foods and food materials in major countries in the Region and to contribute to
the promotion and easier business developments of Japanese food industries and
those in East Asian countries by means of exchanging and sharing information and
dialogues on procedures for quality control and measures for resources and
environments in the Region. This investigation was conducted with the help of
specialists in the countries surveyed.
The results of the investigation were discussed at the “International Conference for
Sharing Information on Food Standards in Asia” held at Hotel Mulia Senayan in
Jakarta in Indonesia on February 21, Tuesday, 2012. The Conference was attended
by total 127 participants from 9 ASEAN countries (Cambodia, Indonesia, Lao PDR,
Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam), plus Australia,
China, Korea, Japan, UK, and USA, from those Governments as well as food
industries. The interests of the administrators and food industries in harmonization
of the standards for foods and agricultural products in the ASEAN countries were
very high and the topics were actively discussed.
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Further, the investigation included in this year general information on “Halal”, and
preliminary survey on the Indian market in addition to the previous investigation on
Codex, Korea, China and ASEAN countries, such as Malaysia, Singapore,
Philippines, Indonesia, Thailand, and Vietnam, and preliminary study for
preparation for the Database of the information collected.
2.1 Countries covered by the Investigation:
In the light of marketability (including population), business activities of Japanese
companies possessing overseas subsidiaries and market potential in East Asian
countries, we selected 5 countries in the FY2009 project; the Republic of Korea, the
People's Republic of China, Malaysia, Singapore, and the Philippines. In FY2010, we
added 3 countries; Indonesia, Thailand, and Vietnam, and in the FY2011 project, we
examined the possibility to further expanded to India market.
2.2 Food(s) covered by the Investigation:
When designing the investigation program, the first pilot study covered instant
noodles, carbonated drinks and prepared frozen foods which were considered to be
relatively common in the region for the FY2009 project. Further, the information of
milk was also collected for reference in FY2010. In the FY2011 project, related
regulatory framework and conditions for use of food additives in target countries,
and general information on “Halal” were added and investigated.
2.3 Methods of the Investigation:
This project was conducted by International Life Sciences Institute (ILSI Japan)
with cooperation of ILSI's international network, namely ILSI Korea, ILSI Focal
Point in China and ILSI Southeast Asia Region (ASEAN countries). Practically, the
Investigation was conducted under the following procedures:
(1) ILSI Japan determined survey items and target countries, and designed and
prepared investigation forms.
(2) ILSI Japan sent the investigation program and forms to ILSI branch offices
concerned in the target countries. Local meetings were held as required and
the investigation forms were modified according to conditions in the target
countries.
(3) ILSI branch offices in the target countries filled the investigation results into
the forms in English and prepared the investigation report in each target
country.
(4) ILSI Japan compiled and analyzed the data filled, and translated into
Japanese if needed.
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(5) Investigators in this project extracted the issues for standardization and
harmonization of commodity food standards and conditions for use of food
additives.
(6) ILSI Japan convened an International Conference together with the persons
from relevant Government Agencies, Experts in the Region, participants from
Japanese companies to share and exchange the results.
(7) ILSI Japan published the reports and disseminated those on the ILSI Japan
website.
2.4 Project Team:
ILSI Japan set up the project team within its “International Cooperation
Committee”, an organization of ILSI Japan. The team consisted of members
representing each fields including food standards, methods of analysis, food
additives, “Halal” and market of India. The team designed the program and
proposed items to be investigated. These items were determined based on the
discussions within ILSI branch offices (Korea, China and Southeast Asia Region).
The project team conducted the investigation with the help of ILSI international
network, especially with the following ILSI branch offices.
ILSI Japan branch: Japan
ILSI Korea branch: Korea
ILSI China branch: China (not including Hong Kong and Taiwan)
ILSI Southeast Asia Region branches: Malaysia, Singapore, Philippines,
Indonesia, Thailand, and Vietnam
ILSI Japan
International
Cooperation Committee
ILSI Korea
Person in charge
ILSI China
Person in charge
ILSI Southeast Asia
Region
Person in charge
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2.5 Schedule of the Investigation:
This proposed project was conducted according to the following schedule.
Preliminary investigation and program design: July – September, 2011
Filling in the investigation forms: October – December, 2011
Collection and analyzing the data and extraction of future tasks: January, 2012
International conference: February 21, 2012 (Jakarta, Indonesia)
Preparation of the report: February – March 31, 2012
Duration of the survey program: 9 months
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3. The Investigation Results for Each Country
3.1 Commodity Standards developed by Codex Alimentarius Commission
For defining the contents of "Food Standards", Commodity Standards developed by
Codex Alimentarius Commission1, which could be commonly accepted by member
countries, were used in this investigation as a standard.
3.1.1 Elaboration of Codex Commodity Standards
Figure 3.1-1 shows relationship between Commodity Standards and General
Standards in Codex.
Codex Alimentarius Commission has two types of functionally classified committees;
Commodity Committees which deal with Commodity Standards, and General
Subject Committees which deal with general subjects horizontally applied to overall
foods. Standards developed by the Commodity Committee should be reviewed for
overall foods and be approved by General Subject Committees.
Figure 3.1-1 Commodity Standards developed by Codex Alimentarius Commission
1 Codex Alimentarius Commission is an intergovernmental body established in 1962 by FAO (Food and
Agriculture Organization of the United Nations) and WHO (World Health Organization) to implement the joint FAO/WHO Food Standards Programme. Its purpose is protecting the health of consumers and ensuring fair practices in the food trade through development of international food standards. Food standards developed by Codex Alimentarius Commission are intended to harmonize food standards worldwide under the multilateral trade agreement. http://www.codexalimentarius.net/web/index en.jsp
Name of the Standard
Scope
Description
Essential Composition
and Quality Factor
Food Additives
Contaminant
Hygiene
Weights and Measures
Labelling
Methods of Analysis and
Sampling
Format for Codex
Commodity Standards
Food Additives (GSFA *2 )
Contaminant and Toxin (GSCTFF *3 )
Pesticide Residues (MRLs )
Residues of Veterinary Drugs in Food (MRLs)
Food Hygiene (GPFH *4 and other relevant Text)
Food Labelling (GSLPF *5 and other relevant Text)
Methods of Analysis and Sampling
(RMAS*6 and other relevant Text)
Endorsement by
General Subject Committee
Elaboration of Codex Commodity Standards*1
*1 Procedural Manual : Section III Elaboration of Codex Standards and Related Text
*2 Codex Stan 192-1955 General Standard for Food Additives
*3 Codex Stan 193-1995 General Standard for Contaminants and Toxins in Foods and Feeds
*4 CAC/RCP1-1969 General Principles of Food Hygiene
*5 Codex Stan 1-1985 General Standards for the Labelling of Prepackaged Foods
Only the food additives listed herein are recognized as suitable for use in foods in
conformance with the provisions of this Standard.5 Only food additives that have
been assigned an Acceptable Daily Intake (ADI) or determined, on the basis of other
criteria, to be safe6 by the Joint FAO/WHO Expert Committee on Food Additives
(JECFA)7 and an International Numbering System (INS) designation by Codex will
be considered for inclusion in this Standard. The use of additives in conformance
with this standard is considered to be technologically justified.
1.2 FOODS IN WHICH ADDITIVES MAY BE USED
This Standard sets forth the conditions under which food additives may be used in
all foods, whether or not they have previously been standardized by Codex. The use
of additives in foods standardized by Codex is subject to the conditions of use
established by the Codex commodity standards and this standard. The General
Standard for Food Additives (GSFA) should be the single authoritative reference
point for food additives. Codex commodity committees have the responsibility and
expertise to appraise and justify the technological need for the use of additives in
foods subject to a commodity standard. The information given by the commodity
committees may also be taken into account by the Codex Committee on Food
Additives (CCFA) when considering food additive provisions in similar
non-standardized foods. When a food is not covered by a commodity committee,
CCFA will appraise the technological need.
5 Notwithstanding the provisions of this Section of the General Standard, the lack of reference to a particular
additive or to a particular use of an additive in a food in the General Standard as currently drafted, does not imply that the additive is unsafe or unsuitable for use in food. The Commission shall review the necessity for maintaining this footnote on a regular basis, with a view to its deletion once the General Standard is substantially complete.
6 For the purpose of this standard “determined, on the basis of other criteria, to be safe” means that the use of a food additive does not pose a safety concern under conditions of use described by JECFA as being of no toxicological concern (e.g. use levels defined circumstances).
7 A data base of food additive specifications with their current ADI status, the year of their most recent JECFA evaluation, their assigned INS numbers, etc., are available in English at the JECFA website at FAO. http://www.fao.org/ag/agn/jecfa-additives/search.html?lang=en The database has a query page and background information in English, French, Spanish, Arabic and Chinese. The reports of JECFA are available at the JECFA website at WHO. http://www.who.int/ipcs/food/jecfa/en/
Food categories or individual food items in which the use of food additives is not
acceptable, or where use should be restricted, are defined by this Standard.
1.4 MAXIMUM USE LEVELS FOR FOOD ADDITIVES
The primary objective of establishing maximum use levels for food additives in
various food groups is to ensure that the intake of an additive from all its uses does
not exceed its ADI.
The food additives covered by this Standard and their maximum use levels are based
in part on the food additive provisions of previously established Codex commodity
standards, or upon the request of governments after subjecting the requested
maximum use levels to an appropriate method for verifying the compatibility of a
proposed maximum level with the ADI.
Annex A of this Standard may be used as a first step in this regard. The evaluation of
actual food consumption data is also encouraged.
2. DEFINITIONS
a) Food additive means any substance not normally consumed as a food by itself
and not normally used as a typical ingredient of the food, whether or not it
has nutritive value, the intentional addition of which to food for a
technological (including organoleptic) purpose in the manufacture, processing,
preparation, treatment, packing, packaging, transport or holding of such food
results, or may be reasonably expected to result (directly or indirectly), in it
or its byproducts becoming a component of or otherwise affecting the
characteristics of such foods. The term does not include contaminants or
substances added to food for maintaining or improving nutritional qualities8.
b) Acceptable Daily Intake (ADI) is an estimate by JECFA of the amount of a
food additive, expressed on a body weight basis that can be ingested daily
over a lifetime without appreciable health risk9.
c) Acceptable Daily Intake "Not Specified" (NS) 10 is a term applicable to a food
8 Codex Alimentarius Procedural Manual. 9 Principles for the Safety Assessment of Food Additives and Contaminants in Food, World Health
Organization, (WHO Environmental Health Criteria, No. 70), p. 111 (1987). For the purposes of this Standard, the phrase “without appreciable health risk” means that there is a reasonable certainty of no harm to consumers if an additive is used at levels that do not exceed those in this Standard. The provisions of this Standard do not sanction the use of an additive in a manner that would adversely affect consumer health.
10 For purposes of this Standard, the phrase acceptable daily intake (ADI) “not limited” (NL) has the same meaning as ADI “not specified”. The phrase “acceptable ADI” refers to an evaluation by JECFA, which established safety on the basis of an acceptable level of treatment of food, limited numerically or by GMP,
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substance of very low toxicity for which, on the basis of the available data
(chemical, biochemical, toxicological, and other), the total dietary intake of
the substance, arising from its use at the levels necessary to achieve the
desired effect and from its acceptable background levels in food, does not, in
the opinion of JECFA, represent a hazard to health.
For the above reason, and for reasons stated in individual JECFA evaluations,
establishment of an acceptable daily intake expressed in numerical form is
not deemed necessary by JECFA. An additive meeting the above criterion
must be used within the bounds of good manufacturing practice as defined in
section 3.3 below.
d) Maximum Use Level of an additive is the highest concentration of the
additive determined to be functionally effective in a food or food category and
agreed to be safe by the Codex Alimentarius Commission. It is generally
expressed as mg additive/kg of food.
The maximum use level will not usually correspond to the optimum,
recommended, or typical level of use. Under GMP, the optimum,
recommended, or typical use level will differ for each application of an
additive and is dependent on the intended technical effect and the specific
food in which the additive would be used, taking into account the type of raw
material, food processing and post-manufacture storage, transport and
handling by distributors, retailers, and consumers.
3. GENERAL PRINCIPLES FOR THE USE OF FOOD ADDITIVES
The use of food additives in conformance with this Standard requires adherence to
all the principles set forth in Sections 3.1 – 3.4.
3.1 FOOD ADDITIVE SAFETY
a) Only those food additives shall be endorsed and included in this Standard
that, so far as can be judged on the evidence presently available from JECFA,
present no appreciable health risk to consumers at the use levels proposed.
b) The inclusion of a food additive in this Standard shall have taken into
account any ADI, or equivalent safety assessment established for the additive
by JECFA and its probable daily intake11 from all food sources. Where the
rather than on a toxicologically established ADI.
11 Codex members may provide the CCFA with intake information that may be used by the Committee in establishing maximum use levels. Additionally, the JECFA, at the request of the CCFA, will evaluate intakes of additives based on intake assessments submitted by Codex members responding to a call for data. The CCFA will consider the JECFA evaluations when establishing the maximum use levels for additives.
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food additive is to be used in foods eaten by special groups of consumers (e.g.,
diabetics, those on special medical diets, sick individuals on formulated liquid
diets), account shall be taken of the probable daily intake of the food additive
by those consumers.
c) The quantity of an additive added to food is at or below the maximum use
level and is the lowest level necessary to achieve the intended technical effect.
The maximum use level may be based on the application of the procedures of
Annex A, the intake assessment of Codex members or upon a request by the
CCFA to JECFA for an independent evaluation of national intake
assessments.
3.2 JUSTIFICATION FOR THE USE OF ADDITIVES
The use of food additives is justified only when such use has an advantage, does not
present an appreciable health risk to consumers, does not mislead the consumer, and
serves one or more of the technological functions set out by Codex and the needs set
out from (a) through (d) below, and only where these objectives cannot be achieved by
other means that are economically and technologically practicable:
a) To preserve the nutritional quality of the food; an intentional reduction in the
nutritional quality of a food would be justified in the circumstances dealt with
in sub-paragraph (b) and also in other circumstances where the food does not
constitute a significant item in a normal diet;
b) To provide necessary ingredients or constituents for foods manufactured for
groups of consumers having special dietary needs;
c) To enhance the keeping quality or stability of a food or to improve its
organoleptic properties, provided that this does not change the nature,
substance or quality of the food so as to deceive the consumer;
d) To provide aids in the manufacture, processing, preparation, treatment,
packing, transport or storage of food, provided that the additive is not used to
disguise the effects of the use of faulty raw materials or of undesirable
(including unhygienic) practices or techniques during the course of any of
these activities.
3.3 GOOD MANUFACTURING PRACTICE (GMP)12
All food additives subject to the provisions of this Standard shall be used under
conditions of good manufacturing practice, which include the following:
a) The quantity of the additive added to food shall be limited to the lowest
12 For additional information, see the Codex Alimentarius Commission Procedural Manual. Relations
Between Commodity Committees and General Committees- Food Additives and Contaminants.
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possible level necessary to accomplish its desired effect;
b) The quantity of the additive that becomes a component of food as a result of
its use in the manufacturing, processing or packaging of a food and which is
not intended to accomplish any physical, or other technical effect in the food
itself, is reduced to the extent reasonably possible; and,
c) The additive is of appropriate food grade quality and is prepared and handled
in the same way as a food ingredient.
3.4 SPECIFICATIONS FOR THE IDENTITY AND PURITY OF FOOD
ADDITIVES
Food additives used in accordance with this Standard should be of appropriate food
grade quality and should at all times conform with the applicable Specifications of
Identity and Purity recommended by the Codex Alimentarius Commission13 or, in
the absence of such specifications, with appropriate specifications developed by
responsible national or international bodies. In terms of safety, food grade quality is
achieved by conformance of additives to their specifications as a whole (not merely
with individual criteria) and through their production, storage, transport, and
handling in accordance with GMP.
4. CARRY-OVER OF FOOD ADDITIVES INTO FOODS
4.1 CONDITIONS APPLYING TO CARRY-OVER OF FOOD ADDITIVES FROM
INGREDIENTS AND RAW MATERIALS INTO FOODS
Other than by direct addition, an additive may be present in a food as a result of
carry-over from a raw material or ingredient used to produce the food, provided that:
a) The additive is acceptable for use in the raw materials or other ingredients
(including food additives) according to this Standard;
b) The amount of the additive in the raw materials or other ingredients
(including food additives) does not exceed the maximum use level specified in
this Standard;
c) The food into which the additive is carried over does not contain the additive
in greater quantity than would be introduced by the use of raw materials, or
13 An index (CAC/MISC 6) of all specifications adopted by the Codex Alimentarius Commission, as well as
the year of adoption, is available at the Codex website (http://www.codexalimentarius.net). These specifications, prepared by the JECFA, are also being published in 2006 in the “Combined Compendium of Food Additive Specifications,” FAO JECFA Monographs No. 1, which consists of four volumes and in subsequent JECFA Monographs. The specifications are also available at the JECFA website (http://www.fao.org/ag/agn/jecfa-additives/search.html?lang=en). Although specifications for flavouring agents are not included in the printed compendium, with the exception of those few which have an additional non-flavour technological function, they are included in an online searchable database at the JECFA website at FAO. http://www.fao.org/food/food-safety-quality/scientific-advice/jecfa/jecfa-flav/en/
15 Processing Aid means any substance or material, not including apparatus or utensils, and not consumed as a
food ingredient by itself, intentionally used in the processing of raw materials, foods or its ingredients to fulfill a certain technological purpose during treatment or processing and which may result in the non-intentional but unavoidable presence of residues or derivatives in the final product: Codex Alimentarius Commission Procedural Manual.
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Table 3.1-A Description/Definition (General)
Description / Definition Related Legislation CODEX STAN 192-1995
CAC/GL 66-2008 CODEX STAN 107-1981
General Description/Definitions Definition of food
additives CODEX STAN 192-1995
Food additive means any substance not normally consumed as a food by itself and not normally used as a typical ingredient of the food, whether or not it has nutritive value, the intentional addition of which to food for a technological (including organoleptic) purpose in the manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food results, or may be reasonably expected to result (directly or indirectly), in it or its byproducts becoming a component of or otherwise affecting the characteristics of such foods. The term does not include contaminants or substances added to food for maintaining or improving nutritional qualities.
Flavour GUIDELINES FOR THE USE OF FLAVOURINGS CAC/GL 66-2008
(ア) Flavour is the sum of those characteristics of any material taken in the mouth, perceived principally by the senses of taste and smell, and also the general pain and tactile receptors in the mouth, as received and interpreted by the brain. The perception of flavour is a property of flavourings.
(イ) Flavourings are products that are added to food to impart, modify, or enhance the flavour of food (with the exception of flavour enhancers considered as food additives under the Codex Class Names and the International Numbering System for Food Additives - CAC/GL 36-1989). Flavourings do not include substances that have an exclusively sweet, sour, or salty taste (e.g. sugar, vinegar, and table salt). Flavourings may consist of flavouring substances, natural flavouring complexes, thermal process flavourings or smoke flavourings and mixtures of them and may contain non-flavouring food ingredients (Section 2.3) within the conditions as referred to in 3.5. They are not intended to be consumed as such.
Processing aids CODEX STAN 107-1981
Processing aid means a substance or material not including apparatus or utensils and not consumed as a food ingredient by itself, intentionally used in the processing of raw materials, foods or its ingredients to fulfill a certain technological purpose during treatment or processing and which may result in the non-intentional but unavoidable presence of residues or derivatives in the final product.
Carry-over 4.1 CONDITIONS APPLYING TO CARRY-OVER OF FOOD ADDITIVES Other than by direct addition, an additive may be present in a food as a result of carry-over from a raw material or ingredient used to produce the food, provided that:
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a) The additive is acceptable for use in the raw materials or other ingredients (including food additives) according to this Standard;
b) The amount of the additive in the raw materials or other ingredients (including food additives) does not exceed the maximum use level specified in this Standard;
c) The food into which the additive is carried over does not contain the additive in greater quantity than would be introduced by the use of raw materials, or ingredients under proper technological conditions or manufacturing practice, consistent with the provisions of this standard.
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3.2 Japan
3.2.1 Summary Chart of Relationship between Food Regulatory System and
Commodity Food Standards
Summary chart of relationship between food regulation system and commodity food
standards in Japan is shown in Figure 3.2-1 in a way that Codex Alimentarius
Commission presented in Figure 3.1-1. This section was prepared because it is
important to introduce regulatory framework on foods in Japan for mutual
understanding among member countries.
Figure 3.2-1 Japanese Food Regulatory System
3.2.2 Commodity Food Standards
3.2.2.1 The Law Concerning Standardization and Proper Labelling of Agricultural
and Forestry Products
The law consists of combination of “JAS Standards System” which is voluntary
except for the JAS Standards for Organic Foods, and "the Quality Labelling
Standards System" which mandate for quality labelling purposes including name of
food, raw materials and place/country of origin.
(1) The Quality Labelling Standards System
The Quality Labelling Standards System provides cross-category standards for fresh
foods, processed foods and genetically modified foods, and individual standards for 3
fresh foods and 48 processed foods (see FY2009 Report Table 3.2-1).
Name of the Standard
Scope
Description
Essential Composition
and Quality Factor
Food Additives
Contaminant
Hygiene
Weights and Measures
Labelling
Methods of Analysis and
Sampling
Food Sanitation Act
Standards for Foodstuffs
and Additives- 22 Specific Food Items
Milk and Milk ProductsConcerning Composition
Standards- 35 Milk and milk products
Ministry of Health,
Labour and Welfare(MHLW)
JAS*1 Law
Quality Labelling Standard
for Processed Foods- 48 Commodity Food Items
JAS Standard*2
- 55 Commodity Food Items
Ministry of Agriculture,
Forestry and Fisheries(MAFF)
Act Against UnjustifiablePremiums and Misleading
Representations Fair Competition Code
- 45 Food & Liquor Items
Consumer Affairs Agency (CAA)
Japan Fair Trade Commission (JFTC)
Health Promotion Act
Food with Health Claims-Nutrient Function Claims-Foods for Specified Health
Uses (FOSHU) Food for Special Dietary
UsesNutrition Labeling
CAA consulted by MHLW
Japanese Commodity Standards
Measurement ActMinistry of Economy,
Trade and Industry
*1 Law Concerning Standization and Proper Labelling of Agricultural and Forest Products
*2 voluntary (other than organic foods) standard with the certification system to attach the JAS Mark
*3 New governmental organization started in September 2009
Consumer Affairs Agencycovers
Labelling Provision ofFSA and JAS
(CAA)
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(2) JAS Standards System
JAS Standards mainly stipulate quality, composition, grade and usefulness for food,
forest and agricultural products including silk and rush tatami facing. JAS
Standards System is a certification system to bear JAS marks on the label through
certification by Registered Certifying Bodies. Products should meet to JAS
standards, standards for maintenance and quality control in manufacturing facility,
performance of production process control etc. As of March 2010, JAS Standards for
food define 55 items in five areas (see FY2009 Report Table 3.2-2).
3.2.2.2 Food Sanitation Act and related regulations
Food Sanitation Act stipulates matters related food safety including food additives,
pesticide residues, contaminants and hygiene.
(1) Standards for Foodstuffs and Additives (Notification of Ministry of Health and
Welfare No. 370)
Standards for Foodstuffs and Additives define standards for component, production
and storage for 22 specific food items, in addition to general standards for component,
production, processing and preparation, and storage for food (see FY2009 Report
Table 3.2-3).
(2) Ministerial Ordinance on Compositional Standards for Milk and Milk Products
(Ordinance of Ministry of Health and Welfare No. 52)
For milk and milk products, the ordinance specifically stipulates standards for
component, production, storage and hygiene (see FY2009 Report Table 3.2-4).
3.2.2.3 Fair Competition Code for Labelling of Food Items
Fair Competition Code based on Act against Unjustifiable Premiums and Misleading
Representations stipulates voluntary standards for labelling of food items for
individual firms and industry associations (see FY2009 Report Table 3.2-5), and is
governed by Consumers Affairs Agency and the Fair Trade Commission. When their
activities violate the code, penalty shall be imposed to their business activity. The
Fair Trade Commission could take an action against even an outsider in accordance
with social recognition of the code.
3.2.3 Acts and Regulations related to Food Additives
3.2.3.1 Overview
In Japan, food additives are regulated by the Ministry of Health, Labour and
Welfare (MHLW). The main legal basis for regulation of food additives is found in the
Food Sanitation Act (Act No. 233 of December 24, 1947) and its subsidiary
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legislations including;
- The Food Sanitation Act Enforcement Regulations, July 13, 1948
- MHLW Notification No.370, December 28, 1959 “Specifications and Standards
for Foods, Food Additives, etc.”
- Cabinet Office Ordinance No.45, August 31, 2011 on the criteria of labelling
pursuant to item (1) of Article 19 of Food Sanitation Act
The Act provides that:
1) Substances that are not permitted as food additives are not allowed to be
used as food additives;
2) Permitted food additives that do not comply with specifications prescribed
under the Food Sanitation Act, where such specifications are so described,
are also not allowed to be used as food additives.
3) Manufacturing and/or use of permitted food additives should comply with
standards of manufacture/use, including maximum level of use, prescribed
under the Food Sanitation Act, where such standards are so described.
4) The government is responsible to compile “The Japanese Standards for
Food Additives” to contain the standards and specifications.
Additionally, among some of 55 JAS Mark standards under the Law Concerning
Standardization and Proper Labelling of Agricultural and Forest Products (JAS
Law), use of some food additives are restricted in the food so described. JAS Mark
is voluntary certification system.
JAS Law also has the “Quality Labelling Standard” system. Among several
standards of the system, all processed foods except for alcohol beverage are
regulated by the “Quality Labelling Standard for Processed Foods” (Notification
No.513 of the Ministry of Agriculture, Forestry and Fisheries of March 31, 2000).
Food additives used in processed foods should be labeled in accordance with the
General Description/Definitions Definition of food
additives “Food additives” means substances to be used in or on food, in the process of the manufacturing of food or for the purpose of the processing or preserving of food, by adding, mixing, infiltrating, or other means.
Flavour Flavour is classified in the food additive category. “Natural flavouring agent” means food additives, intended for use for flavouring food, which are substances obtained from animals or plants, or mixtures thereof.
FSA Article 4, 3
Processing aids Processing aid is classified in the food additive category.
“Processing aids” means substances added to a food in processing the food, which are: 1) removed from the food before the completion of the food, 2) derived from raw materials of the food and converted into components normally included in the food but do not significantly increase the amounts of the components, or 3) present in the finished food at insignificant levels but do not have any technical or functional effect of these components on the food.
Article 21, 1-e, of the Food Sanitation Act Enforcement Regulations, 1948
Carry-over “Carry-over” is defined, but only for labelling purposes.
“Carry-over” means substances which are used in manufacturing or processing raw materials of a food and not used in manufacturing or processing the food and which are present in the finished product at levels less than those normally required to achieve any technical or functional effect in the food.
Article 21, 1-e, of the Food Sanitation Act Enforcement Regulations, 1948
Specific descriptions / Additional explanations 1 List of Designated Food
Additives Food additive is listed as “Designated food additives” on the attached table 1 of the Food Sanitation Act Enforcement Regulations, 1948. There is no classification of function in these lists. As of March 2012, 423 additives are designated as approved by the MHLW.
Substances that were already marketed or used on the date of the amendment of the FSA in 1995 were listed on the Existing Food Additives. The MHLW is conducting continuous survey of marketing and use of food additives on the list. As of March 2012, there are 365 Existing Food Additives in the list.
3 List of Plant or Animal sources for Flavouring agents
“List of plant or animal sources of natural flavourings” is given in Appendix 2, the CAA Notice, No. 377, 2010. This list is for labelling of “Natural flavouring agents” and is NOT a positive list of source of flavouring agents.
4 List of substances which are generally provided for eating or drinking as foods and are used as food additives as well
Substances that are both generally provided for eating or drinking as foods and used as food additives have been excluded from the designation system. “List of substances which are generally provided for eating or drinking as foods and which are used as food additives” is given in Appendix 3, the CAA Notice, No. 377, 2010.
Official publication and/or gazette for food additives
Regarding additives for which the specifications and standards have been established pursuant to the provisions of Article 11, paragraph 1 and additives for which the labelling standards have been established pursuant to the provisions of Article 19, paragraph 1, the MHLW shall compile the Japanese Standards of Food Additives to contain such specifications and standards.
Food Categories Food Sanitation Act JAS Law (voluntary standards)
Scope and/or Description Codex stan 249-2006 (Standard for Instant Noodles), (06.4.3) Pre-cooked pastas and noodles and like products
Standards for “Instant Noodles” is defined in Food Sanitation Act, but it only includes specification and standards of storage for oil-processed type Noodles. Limitation of use of some food additives to Instant Noodles (including their attached soup powder) are defined at JSFA.
Positive List (limitation in use)
Positive and/or Negative List
Use Limitation and/or Maximum Level, if any
“JAS” Law:The Law Concerning Standardization and Proper Labelling of Agriculture and Forestry Products.
Table 3.2-2 Case Study 2 Carbonated Soft Drinks
Codex Commodity Standards or GFSA
Food Categories Food Sanitation Act JAS Law (voluntary standards)
Cider and Perry In “the Standards for use of Food Additives”, maximum level of several food additives in “non-alcoholic beverage” is set and some food additives are prohibited to be used in “non-alcoholic beverages”.
Table 3.2-3 Case Study 3 Prepared Frozen Foods
Codex Commodity Standards or GFSA
Food Categories Food Sanitation Act JAS Law (voluntary standard)
Scope and/or Description Not applicable
Specifications of prepared frozen foods are described in FSA.
No positive/negative list on food additives in it.
The restrictions in use of food additives are applied to the foods to be frozen, not to the frozen foods.
Positive List (limitation in use)
Positive and/or Negative List
Use Limitation and/or Maximum Level, if any
Table 3.2-4 Case Study 4 Cow’s Milk
Codex Commodity Standards or GFSA
Food Categories Food Sanitation Act JAS Law (voluntary standard)
Scope and/or Description 01.1.1.1 Milk (plain) Use of food additives in milk is prohibited or restricted by FSA
additives will undergo scientific evaluation regarding its safety, technical necessity
and effectiveness of its use. In case of some natural additives or additives used for
sanitation of apparatus, of which criteria and standards are not published under
part 1 of Article 7, the provider may submit (or KFDA may ask the provider to
submit) a dossier according to another notification to establish a (so-called)
“temporal standards and specifications”.
3.3.3.7 Labelling of Food Additives
There are some rules in declaration of food additives as ingredients of foods. They
are regulated in attachment 1 of KFLS. There are some categories including of which
usage should be declared in addition to their names, of which names for declaration
are limited, which should be declared with their main function names, or which can
be declared as a group with the group name.
3.3.3.8 KFAC (Korean Food Additive Code)
As mentioned above, KFAC contains specifications and standards of each listed food
additives. It also contains General Provisions; Manufacturing standards; General
principle in use of food additives; General test methods; and Reagents & Standards
used in Analysis. There also be specifications for some preparations of specific
additives, and general standard for mixed preparations.
3.3.4 Case Study
In order to compare the contents of food standards set in Food Code and those in KS
standard, Instant Noodles, Carbonated Soft Drinks, Prepared Frozen Foods, and
Cow’s Milk were chosen as examples.
(1) Instant Noodles (Table 3.3-2)
Food Code regulates food additives that should not be detected in noodles. There are
several detailed voluntary standards of fried noodles and dried noodles in KS
standard, but those standards do not have restrictions of food additives beyond those
in regulated in Food Code.
(2) Carbonated Soft Drinks (Table 3.3-3)
The same as the case in Noodles, the restriction in use of food additives for
carbonated soft drinks are only described in Food Code, and KS standards has no
optional restrictions beyond those in Food Code.
(3) Prepared Frozen Foods (Table 3.3-4)
Similar to the style in Japan, Food Code has the standard of Prepared Frozen Foods
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and KS standard has more detailed individual standards such as for prepared frozen
dumplings and frozen battered shrimps. But the restriction in use of food additives
are only described in Food Code, and KS standards has no optional restrictions
beyond those in Food Code.
(4) Cow’s Milk (Table 3.3-5)
Prohibitions and/or restrictions in use of food additives for Cow’s Milk are described
in Food Code. Standards for, Milk and Milk products in KS standards has no
optional restrictions beyond those in Food Code.
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Table 3.3-A Description/Definition (General) Description/Definition Reference Related legislation Korea Food Sanitation Act (KFSA), 2010
Korea Food Additive Code (KFAC), 2010, 2011 Korea Food Code (KFC), 2010
KFSA (refer to PDF file) KFAC (http://www.kfda.go.kr/fa/ebook/egongjeon_intro.jsp ; English)
Korea Food Code (http://www.kfda.go.kr/eng/eng/index.do?nMenuCode=43&searchKeyCode=122&page=1&mode=view&boardSeq=66020 ; English)
General Description/Definitions Definition of food
additives Food additives is defined in Article 2.2 of KFSA as “materials added to or mixed with foods or materials used for wetting foods in the processes of manufacturing, processing, or preserving foods. In such cases, food additives shall include materials used in sterilizing or disinfecting apparatus, containers or packages, which may be transferred to foods in an indirect manner”.
FSA Article 2. 2
Flavours Flavourings is recognized as one category of food additives. There is no clear definition of “Flavourings” in KFSA, but from its standard of use in KFAC, it is assumed to be defined as “additives used (only) for adding flavourings for foods”. There are two groups in food additives used for flavourings. One is ‘synthetic flavouring substances’ in synthetic additives. All of the permitted chemicals used for flavourings are classified in this group, but there are some substances that also appear in KFAC individually with their names because they have obligatory specifications. Another group is ‘natural flavouring substances’ in natural additives. It is defined as follows and listed by the name of raw materials. There also be a special limitation in career, extraction solvents, etc.: “These materials are obtained from the following origins by processes such as extraction and distillation. They are used to add or enhance aroma. There are refined oils, extracts, and Oleoresin (spice oleoresin whose specification is separately set is excluded). Water, ethanol, vegetable oil can be added for preserving quality”.
Korea FoodNara Glossary Site (Korean) http://www.foodnara.go.kr/foodnara/dic-list.do?seq=6867&mid=S07&boardId=dictionary&searchKey=착향료&search Type=1&page=1
KFAC I. General Provisions (3) p.1. http://www.kfda.go.kr/fa/index.do?page_gubun=1&serialno=107&nMenuCode=12&page_gubun=1&gongjeoncategory=2&keyfield=foodaddtivename&key=천연착향료&page=1 (Appendix 1)
Processing aids There is no clear definition of ‘Processing aids’ in KFSA, but the glossary on KFDA WEB site (only in Korean) defines it as follows: “They are food additives that are not specified their function but are used in foods during manufacturing or processing, or used for other purposes. Representatively includes n-Hexane.” The concept which is similar to its definition in Codex can be found in Article 1.A.7) c) (9) of “Detailed labelling Standard”(Attachment 1 to KFLS) as follows: “When a food additive is added during manufacturing but removed from the final product, declaration of such additive can be exempted.”
Glossary of Food Additives (Korean) http://www.kfda.go.kr/fa/index.do?nMenuCode=9&mode=view&boardSeq=8271
Carry-over It is not defined in KFAC, but its principle is partially appeared in Article 2. 5. 3) (2) of KFC as follows: “If a food additive that cannot be used in a food is derived from a raw material for which the food additive can be used, the restriction on the use of food additives may not be applied within the range of such deriving the raw material.”
Korea Food Code (2-1-8)
Korea Food Code Article 2.5.3 http://www.kfda.go.kr/eng/eng/index.do?nMenuCode=43&searchKeyCode=122&page=1&mode=view&boardSeq=66020
Table 3.3-B Description/Definition (Specific) Description/Definition Reference Related legislation Korea Food Sanitation Act (KFSA), 2010
Korea Food Code (KFC), 2010 Korea Food Additives Code (KFAC), 2010, 2011
Specific descriptions / Additional explanations 1 List of Designated Food
Additives As of November 2010 (Notification #2010-82), 602 food additives in total are approved with the permission to use in respectively designated food groups. Standard and specification of the synthetic additives (400 items), natural additives (195 items) and mixed additives (7 items) are listed in the current KFAC.
The e-book of English version still contains those officially deleted which are summarized in the appendix 2 (33 synthetic additives and 12 natural additives deleted from KFAC).
Flavouring agents of which synthetic ones are covered under the
Article 3_ A, 3_ B, 3_ C of Korea Food Additive Code
item No 424 of synthetic food additives list can be accessed separately in the KFAC.
2 List of Existing Food Additives
Not applicable in Korea.
3 List of Plant or Animal sources for Flavouring agents
Natural Flavourings are categorized as one of Natural additives, and raw materials of Natural flavourings are listed in a table of this item in KFAC. The list consists of 272 of each substances and general description “raw materials that are appropriate for 2. Requirements for Raw Materials. Common in Food Codes”.
4 List of substances which are generally provided for eating or drinking as foods and are used as food additives as well
Not applicable in Korea.
Negative list (if any) In principle, the positive list of food additives are managed under the Korea Food Sanitation Act. However, for some individual food items (e.g. Instant noodles, carbonated beverages, etc.), negative list of food additives are described.
Specifications of Food Additives, Weights and Measures, Contaminants, Methods of Analysis and Sampling, Standards of manufacturing of food additives
General provisions of KFAC provides the information of [weight, volume and temperature], [tests], [container], and [definition of terms].
KFAC main text provides standards for manufacturing and preparation, general standards for food additive used in foods, food contact surface sanitizing solutions and general test methods as well.
Fried Noodles (KS H 2508), Dried Noodles (KS H 2505), Raw Noodles (KS H 2506), and Cooked Noodles (KS H 2507)
Noodles were specified as fried noodles and non-fried noodles.
Tar colour should not be detected.
KS H 2505 KS H 2506 KS H 2507 KS H 2508
Refer to the table 3.3-8 of the report (p 36, ILSI Japan 2010)
Positive and/or Negative List
Use Limitation and/or Maximum Level, if any
Table 3.3-3 Case Study 2 Carbonated Soft Drinks
Food Sanitation Act KS (voluntary standards)
Scope and/or Description Specification of carbonated beverages are described in Korea Food Code- Carbonated beverages, Carbonated water.
Positive/negative list on food additives (Korea Food Additives Code).
http://safefood.kfda.go.kr/RS/food_eng_menu2.jsp?menu=040&level=2&step_2=011 (English) Korea Food Additives Code http://www.kfda.go.kr/fa/ebook/egongjeon_intro.jsp (English)
Carbonated soft drinks
No positive/negative list included. It is recommended to follow the Korea Food Code.
KS H 2016
Positive and/or Negative List
Use Limitation and/or Maximum Level, if any
Some food additives are allowed to use in carbonated beverages and maximum levels in soft drinks are set as below: - Preservatives: Benzoic acid, sodium benzoate, potassium benzoate, and calcium benzoate less than 0.6g/kg are permitted to only carbonated beverages (excluding carbonated water). - Ester Gum less than 0.1/kg
- Manganese gluconate (no maximum level specified)
Some food additives are not allowed to use in carbonated beverages:
-Food Red No.2 -Food Red No. 2 Aluminum Lake.
Table 3.3-4 Case Study 3 Prepared Frozen Foods
Food Sanitation Act KS (voluntary standards)
Scope and/or Description Food additive standards for frozen food should comply to those for respective food item as designated in the Korea Food Code and/or Food Additive Code. “Frozen food” means a food made by filling the manufactured, processed, cooked food into container and packaging materials after freezing treatment for the purpose of long-term storage.
(1) Frozen food not requiring heat process before consumption: Frozen food that can be consumed without a separate heating process.
(2) Frozen food requiring heating process before consumption: Frozen food that can be consumed only after a separate heating process.
Korea Food Code 3-1-2 (English; http://www.kfda.go.kr/eng/eng/index.do?nMenuCode=43&searchKeyCode=122&page=1&mode=view&boardSeq=66020)
Frozen prepared dumplings (KS H 4001), Frozen prepared croquet (KS H 4002), Frozen battered Shrimps (KS H 4003), Frozen Fried Pork (KS H 4004), and Frozen Fried Fish (KS H 6032) No positive/negative List is included. Generally, it should comply the Korea Food Code and/or Food Additive Code.
KS H 4001 KS H 4002 KS H 4003 KS H 4004 KS H 6032 Positive and/or Negative
Scope and/or Description Milk is defined as the milk pasteurized or sterilized.
Use of food additives in milk is prohibited or restricted under the Korea FSA.
(Sanitary control for livestock products has designated milks for milk, fortified milk, reconstituted milk, and lactic acid bacteria added milk.)
Processing of Livestock Products Act. Article 4.2. “SANITARY CONTROL FOR LIVESTOCK PROOUCTS” Notification on Standard and Specification of Livestock Products (No. 2010-2) http://www.qia.go.kr/viewwebQiaCom.do?id=7660&type=1_41jgbz (Korean)
There is no positive/negative list in KS. Milk was included in the milks (KS H 2195) in KS.
completely correspond to Codex Standards. For “Weights and Measures”, JJF1070
pursuant to Measurement Act like in Japan, and standards set by AQSIQ shall be
applied.
Figure 3.4-3 Summary of Food Standards in China
For specific examples, see summary of food standards (Figure 3.4-4~6) described in
“3.4.4 Case Study” Commodity Standards below. Plotting the corresponding items of
GB standards and other standards on the Codex Standards, it was found that the
Chinese food standards relatively correspond to the Codex Standards. Though the
same may not be said for all foods, the Chinese standards are well organized from
the viewpoint of consistency with Codex Standards.
3.4.3 Acts and Regulations related to Food Additives
3.4.3.1 Overview
“Standard” of China is equivalent to the "Specifications" or "Standards" in Japan,
according to the Standardization Act, and is controlled by National Standardization
Management Committee. There are over 1,800 national food safety standards and
over 7,000 local food safety standards, and over 70,000 company standards and so
much overlapped. In this context, Food Safety Act is to arrange, integrate and unify
the standards. The Act allows State Council Department only to be responsible for
establishing and publishing the National Standards. Accordingly, where the
National Standard is defined the national standard is the only one to follow.
China's food additive regulations are all basically listed in the “Standards on Use of
Food Additives by GB2760 (from now on, unless otherwise specified, appendix or
Name of the Standard
Scope
Description
Essential Composition and Quality Factor
Food Additives
Contaminant
Hygiene
Weights and Measures
Labelling
Methods of Analysis and Sampling
National and industrial standards of ingredients and raw materials
GBT 4789 Series std of Microb. examination of food hygieneGBT 5009 Series stds of foodhygienic analysis methods -Physical and chemical setion
GB 2760 ‘Hygienic standards for uses of food additives’GB14880 ’Hygienic standards for the use of nutritional fortification substances in foods’
GB 2762 ‘Max levels in foods of Contaminants’; GB 2763 ‘Maximun residues limits for pesticides in foods’Veterinary drug MRLs by MOA
‘Administrative provisions ofmetrological supervision for products in prepackages with fixed contents’ by AQSIQ
Format for CODEXCommodity Standards
GB 7718 ‘General Standard for Prepackage Foood Labeling’;GB 13432 ‘General standards for the labeling of prepackaged foods for special dietary uses’‘General Std for Nutrition Label’
Food Standards in CHINA Food Standards in CHINA
Hygiene stds for food/categoriesHygiene stds for food factories
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table mean those referred to from GB2760)”. This standard defines general
principals for the use of food additives including flavours and processing aids, and
imposes food producers on duties not to use other chemicals than food additives nor
substances harmful to human bodies in the food production. Furthermore, there are
limitations on a type of food additives used, a food category to be added, and a dose to
add. Use of food additives is only approved when it is necessary of the technological
merits in the food production and regarded as safe through a scientific evaluation. A
General Description/Definitions Definition of food
additives “Food additives” refer to the artificially or chemically synthetic or natural substances to be added to foods in order to improve food quality and colour, flavour and taste, and for the need of preservation and processing technology, including nutritional fortification substances, flavouring agents and processing aids.
GB2760-2011 Article 2. Terms and definitions:
2.1 Food additive
Flavours The flavouring agents and flavouring essences are used in foods in order to create, change or improve the flavour of foods. The flavouring agents are usually made into flavouring essences for flavouring the food, but some of them may be directly added into the food. The flavouring agents and flavouring essences exclude the substances which only make the food sweet, sour or salty and the flavour enhancer. Flavours are not used as a directly consumed ingredient.
GB2760-2011 Annex B. Provision on Use of Flavouring Agents: B.1 Principles for application of flavouring agents and flavouring essences
Processing aids Food processing aids refer to various kinds of substances to enable food processing to go with a swing smoothly, regardless of irrelative to food itself, for example, nutritional substances for filtration aids, clarification clarifiers, absorption absorbents, lubrication lubricants, decoating mold release agents, decolouring agents, peeling agents, solvents extraction solvents, and nutritional substances for fermentation, etc. Processing aids are not allowed to remain in the processed food (where they are used) unless otherwise specified.
GB2760-2011 Article 2. Terms and definitions:
2.4 Food processing aid; Annex C. Provisions on Use of Processing Aid for Food Industry (“processing aid”): C.1 Principles for use of processing aids
Carry-over Besides direct addition, the food additives can be brought introduced into the foods through the food ingredients in the following cases;
1. The use of the food additive in the food ingredients can only be allowed according to this standard;
2. The level of use of this additive in the food ingredients should not exceed the allowable maximum level;
3. These ingredients shall be applied in the normal production
GB2760-2011 Article 3. Principles for use of food additives: 3.4 Carry-over principles
process. And the content of this additive in the food should not exceed the level that is carried over by the ingredients;
4. The content of this additive brought introduced into the food by the ingredients shall be obviously lower than the usually required level of it that which is directly added to this the food.
Specific Descriptions/Definitions 1 List of Designated Food
Additives There is no one list showing all the approved food additives and it is published as a notice whenever approved and later they will be listed as new approved additives in total as GB3760 or GB14880 is revised.
2 List of Existing Food Additives
Not applicable in China.
3 List of Plant or Animal sources for Flavouring agents
A list of natural flavouring agents is shown in Appendix B.2 of GB2760.
4 List of substances which are generally provided for eating or drinking as foods and are used as food additives as well
Not applicable in China.
Negative list (if any) There is no negative list of food additives under GB2760
Specifications of Food Additives, Weights and Measures, Contaminants, Methods of Analysis and Sampling, Standards of manufacturing of food additives
The specifications of food additive, including analytical method, are part of National Food Safety Standards, which should be issued by Ministry of Health. Nevertheless, there are still some food additives that lack of specification, and MOH is working on that to cover the gap as soon as possible.
GB 2760 ‘Hygienic standards for uses of food additives’GB14880 ’Hygienic standards for the use of nutritional fortification substances in foods’
GB 2762 ‘Max levels in foods of Contaminants’; GB 2763 ‘Maximun residues limits for pesticides in foods’Veterinary drug MRLs by MOA
GB17400 Hygienic Standard for Instant Noodle
‘Administrative provisions ofmetrological supervision for products in prepackages with fixed contents’ by AQSIQ
Format for CODEXCommodity Standards
Food Standards in CHINAFood Standards in CHINA
LS/T 3211 Industry Standard for Instant Noddle
GB 7718 ‘General Standard for Prepackage Foood Labeling’;GB 13432 ‘General standards for the labeling of prepackaged foods for special dietary uses’‘General Std for Nutrition Label’
GBT 4789 Series std of Microb. examination of food hygieneGBT 5009 Series stds of foodhygienic analysis methods -Physical and chemical setion
Figure 3.4-4 Summary of Food Standards in Instant Noodles
(2) Carbonated Soft Drinks
Name of the Standard
Scope
Description
Essential Composition and Quality Factor
Food Additives
Contaminant
Hygiene
Weights and Measures
Labelling
Methods of Analysis and Sampling
GB 2760 ‘Hygienic standards for uses of food additives’GB14880 ’Hygienic standards for the use of nutritional fortification substances in foods’
GB 2762 ‘Max levels in foods of Contaminants’; GB 2763 ‘Maximun residues limits for pesticides in foods’Veterinary drug MRLs by MOA
GB 2759.2 Hygiene standard for Carbonated beverage
‘Administrative provisions ofmetrological supervision for products in prepackages with fixed contents’ by AQSIQ
Format for CODEXCommodity Standards
Food Standards in CHINA
Food Standards in CHINA
GB10789 General std of beverage5.1 Carbonated beverages
5.1.1 juice containing type5.1.2 fruit flavored type5.1.3 cola type……
GB/T10792 Carbonated Beverage
GB 7718 ‘General Standard for Prepackage Foood Labeling’;GB 13432 ‘General standards for the labeling of prepackaged foods for special dietary uses’‘General Std for Nutrition Label’
GBT 4789 Series std of Microb. examination of food hygieneGBT 5009 Series stds of foodhygienic analysis methods -Physical and chemical setion
GB/T12143.4 Assay method of CO2 in Carbonated beverages
Figure 3.4-5 Summary of Food Standards in Carbonated Soft Drinks
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(3) Prepared Frozen Foods
Name of the Standard
Scope
Description
Essential Composition and Quality Factor
Food Additives
Contaminant
Hygiene
Weights and Measures
Labelling
Methods of Analysis and Sampling
GB 2760 ‘Hygienic standards for uses of food additives’GB14880 ’Hygienic standards for the use of nutritional fortification substances in foods’
GB 2762 ‘Max levels in foods of Contaminants’; GB 2763 ‘Maximun residues limits for pesticides in foods’Veterinary drug MRLs by MOA
GB 19295 Hygienic standards for quick frozen and prepacked food made of wheat flour and rice
‘Administrative provisions ofmetrological supervision for products in prepackages with fixed contents’ by AQSIQ
Format for CODEXCommodity Standards
Food Standards in CHINA
Food Standards in CHINA
GB 2707 Hygienic standard for fresh (frozen) meat of livestockGB 2715 Hygienic std for grainsGB 2733 Hygienic standards for fresh (frozen) marine products of animal origin
GB 7718 ‘General Standard for Prepackage Foood Labeling’;GB 13432 ‘General standards for the labeling of prepackaged foods for special dietary uses’‘General Std for Nutrition Label’
GBT 4789 Series std of Microb. examination of food hygieneGBT 5009 Series stds of foodhygienic analysis methods -Physical and chemical setion
Figure 3.4-6 Summary of Food Standards in Prepared Frozen Foods
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Table 3.4-1 Case Study Instant Noodles, Carbonated Soft Drinks, Prepared Frozen Foods, and Cow’s Milk Food Categories Food Categories in GB2760 Reference
1. Instant Noodles 06.0 Cereals and cereal products 06.03 Wheat flour and its product 06.03.01 Wheat flour 06.03.01.01 All-purpose wheat flour 06.03.02 Wheat flour product 06.07 Pre-cooked (instant) noodles and rice
Accessories should be compliant with requirement of “12.0 Condiment” and/or “4.2.2.2 Dried Vegetable”, etc.
2. Carbonated Soft Drinks 14.0 Beverage 14.04 Water-based flavoured beverage 14.04.01 Carbonated drink 14.04.01.01 Cola type carbonated drink 14.04.01.02 Other carbonated drink
3. Prepared Frozen Foods 06.0 Cereals and cereal products 06.03 Wheat flour and its product 06.03.01 Wheat flour 06.03.01.01 All-purpose wheat flour 06.03.01.02 Special wheat flour 06.03.02 Wheat flour product 06.03.02.01 Fresh pasta 06.08 Frozen rice and flour product 06.1 Filling for grain product
Product with filling, e.g., meat or veg, should meet corresponding requirement of Food Additives for meat or veg in GB2760.
4. Cow’s Milk 01.0 Milk and dairy product 01.01 Pasteurized milk, sterilized milk and recombined
Cow’s Milk is not allowed to add flavouring agent and flavouring essence.
In GB2760-2011, the Table of allowed Food Additives (A.1) is organized by the name of food additives instead of Food Categories. There is not any “Voluntary Standard” for use of Food Additives in China.
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3.5 Southeast Asia (Malaysia, Singapore, Philippines, Indonesia, Thailand,
Vietnam)
3.5.1 Malaysia
3.5.1.1 Food Administration
Main administrative bodies responsible for food safety and hygiene control in
Malaysia are Ministry of Agriculture and Agro-Based Industry and Ministry of
Health. Their main roles are shown in Table 3.5-1.
Table 3.5-1 Food Safety Control System in Malaysia
Safety and hygiene control for production and primary processing
Safety and hygiene control for processed foods
Ministry of Agriculture and Agro-Based Industry (MOA) Ministry of Health (MOH)
Agricultural products Department of Agriculture (DOA)
Food Safety and Quality Division (FSQD)
Marine Products Fisheries Department (DOF)
Livestock products Department of Veterinary Services (DVS)
3.5.1.2 Acts and Regulations related to Commodity Standards
Major acts and regulations related to Commodity Standards are presented in
Figure 3.5-1.
Figure 3.5-1 Malaysian Commodity Standards and Relevant Laws
Name of the Standard
Scope
Description
Essential Composition
and Quality Factor
Food Additives
Contaminant
Hygiene
Weights and Measures
Labelling
Methods of Analysis
and Sampling
Food Act-1983Food Regulatioon-1985
General Labeling Requirements
General Food Additives…
Standards andParticular Labeling
Requirements-363 Food Items
Ministry of Health (MOH)
Standards of Malaysia
Act-1996<Malaysian Standard>
- 224 Commodity Food Items
Department of StandardsMinistry of Science, Technology
and Innovation(MOSTI)
Halal FoodMS 1500:2009
Halal Industry Development
Corporation:HDC
Food Hygiene
Regulation-2009 Special Requirement for
Meat, Fish, Ice cream and
frozen confection, milk, Ice
Ministry of Health
(MOH)
Malaysia Commodity Standards
- 66 -
3.5.1.3 Food Act (jurisdiction : MOH)
(1) Food Act- 198328
The Food Act is a key law in food administration. It was enforced to protect the
public against health hazards and fraud in the preparation, sale and use of foods.
The Act stipulates permissible range in the preparation, sale and use of foods. It
gives legal authority to relevant agencies to carry out their duties in implementing
the Act. Such legal authority includes the power of the Minister of Health to
stipulate the supplementary provisions compiled as Food Regulations-1985.
(2) Food Regulations-198529
Supplementary provisions are compiled in Food Regulation-1985. Food
Regulation-1985 is continuously updated on amendment and newly setting of
regulations. Food Regulation-1985 provides requirements for labelling, food
additives and supplement, packaging, contaminants, bacterial toxin etc., and
Standards and Particular Labelling Requirements for 363 food items (FY2009
Report Table 3.5-2). It stipulated minimum definition, component standard and
special labelling requirements.
(3) Food Hygiene Regulations-200930
Food Hygiene Regulation-2009 regulates hygienic requirements against those who
handle foods, as well as the conduct and maintenance of food premises. A food
premise is defined in the Regulation as a place "used for or in connection with the
preparation, preservation, packaging, storage, conveyance, distribution or sale of
any food, or the relabelling, reprocessing or reconditioning of any food”. The
Regulation sets Special Requirements for Meat, Fish, Ice cream, and Frozen
confection, Milk, and Ice in handling, preparation, packaging, supply, storage and
sale. For vending machine, same special regulation is stipulated.
3.5.1.4 Malaysian Standards
As commodity standards, Malaysian Standards (MS) stipulated by Ministry of
Science, Technology and Innovation (MOSTI) occupies important place in food
regulations. They are national standards for all industries pursuant to ISO, but are
basically voluntary standards.
Malaysian Standards shown in FY2009 Report Table 3.5-3 are in the same format
Related legislation Food Regulations 1985 http://fsis2.moh.gov.my/fosimv2/HOM/frmHOMFARSec.aspx?id=21
General Description/Definitions Definition of food
additives Food additives are defined in the Food Regulations as follows:
“Food additive means any safe substance that is intentionally introduced into or on a food in small quantities in order to affect the food’s keeping quality, texture, consistency, appearance, odour, taste, alkalinity, or acidity, or to serve any other technological function in the manufacture, processing, preparation, treatment, packing, packaging, transport, or storage of the food, and that results or may be reasonably expected to result directly or indirectly in the substance or any of its by-products becoming a component of, or otherwise affecting the characteristics of, the food, and includes any preservative, colouring substance, flavouring substance, flavour enhancer, antioxidant and food conditioner, but shall not include added nutrient, incidental constituent or salt.”
Food Regulations 1985, Part V Regulation No. 19 (1)
Flavours “Flavouring substance” means any substance that, when added to food, is capable of imparting flavour to that food and includes spices specified in regulation 286 to 333. “Natural Flavouring Substance” means any flavouring substance obtained exclusively by physical processes from vegetable, fruit or animal, either in their natural state or processed, for human consumption. “Nature Identical Flavouring Substance” means any flavouring substance chemically isolated from aromatic raw materials or obtained synthetically, and are chemically identical to substances present in natural products intended for human consumption, either processed or not.
Food Regulations 1985, Part V Regulation No. 22 (1) Food Regulations 1985, Part V Regulation No. 22 (2) (a) Food Regulations 1985, Part V Regulation No. 22 (2) (b)
Processing aids Processing aids are considered as food additives under the functional class of “food conditioner”.
Food Regulations 1985, Part V Regulation No. 25 (1)
Carry-over “Carry-over” principle is described in general in the Food Regulations, with restricted list of additives allowed to be carried over for infant formula.
Food Regulations 1985, Part V Regulation No. 19 (5);
Specifications of Food Additives, Weights and Measures, Contaminants, Methods of Analysis and Sampling, Standards of manufacturing of food additives
Found in Malaysian Standard 1282 Parts 1-8 for acidity regulator; preservative; antioxidant; flavour enhancer; stabilizer, thickener and gelling agent; solvent; anticaking agent; and colouring substance.
MS 1282: Part 1: 1992 MS 1282: Part 2: 1992 MS 1282: Part 3: 1992 MS 1282: Part 4: 1992 MS 1282: Part 5: 1992 MS 1282: Part 6: 1992 MS 1282: Part 7: 1992 MS 1282: Part 8: 1995
Official publication and/or gazette for food additives
No official publication and/or gazette for food additives. However, updates on food additives are announced on the FSQD, MOH, Malaysia website.
Related legislation Food Regulations http://www.ava.gov.sg/NR/rdonlyres/0CA18578-7610-4917-BB67-C7DF4B96504B/19280/2web_SOF_FoodRegulations15April2011.pdf
General Description/Definitions Definition of food
additives “Food additive includes –
i) all substances, which are components of food, the intended use of which results or may reasonably be expected to result, directly or indirectly, in their affecting the characteristics of food but does not include any foreign substance mixed with food as a result of contamination, or improper handling of the food during the preparation, processing, packing or storage of the food; and
ii) anti-caking agents, anti-foaming agents, anti-oxidants, sweetening agents, chemical preservatives, colouring matters, emulsifiers or stabilizers, flavouring agents, flavour enhancers, humectants, nutrient supplements, sequestrants and other general purpose food additives.”
Food Regulations, Part I, Definitions
Flavours “Flavour Agent” means any wholesome substance that when added or applied to food is capable of imparting taste or odour, or both, to a food. “Natural Flavouring Agents” shall include natural flavouring essences, spices and condiments. “Synthetic Flavouring Essences or Extracts” shall include any artificial flavour or imitation flavour which may resemble the sapid or odoriferous principles of an aromatic plant, fruit or vegetable or any other food, except that the flavouring principle shall be derived in whole, or in part, from either chemical synthesis or any other sources that does not involve extraction or isolation therefrom of the sapid or odoriferous principles present in an aromatic plant, fruit or vegetable or any other food.
Food Regulations, Part III, Regulation No. 22 (1) Food Regulations, Part III, Regulation No. 22 (5) Food Regulations, Part III, Regulation No. 22 (9)
Processing aids “Processing Aids” are considered as “General Purpose Food Additives”, which means any substance which serves a useful and specific purpose during either the processing or packing of a food and shall include processing aid.
Food Regulations, Part III, Regulation No. 28 (1)
Carry-over Food ingredients that are added to foods may also contain food additives for the types of additives permitted and in accordance with the levels specified for the food ingredients.
Related legislation Food Regulations http://www.ava.gov.sg/NR/rdonlyres/0CA18578-7610-4917-BB67-C7DF4B96504B/19280/2web_SOF_FoodRegulations15April2011.pdf
Specific Descriptions/Definitions 1 List of Designated Food
Additives Anti-caking agents, anti-foaming agents, anti-oxidants, sweetening agents, chemical preservatives, colouring matter, emulsifiers and stabilizers, flavouring agents, flavour enhancers, humectants, nutrient supplements, sequestrants, gaseous packaging agent, general purpose food additives
Related legislation Department of Health Administration Order No. 88-A s.1984 on Regulatory Guidelines Concern Food Additives
Department of Health, Food and Drug Administration Circular No. 2006-016 on Updated List of Food Additives
http://www.fda.gov.ph/AO/ao%2088a%20s.%201984.pdf
http://www.fda.gov.ph/BC%202006-016.pdf
General Description/Definitions Definition of food
additives Food additives are defined in the Food, Drug and Cosmetic Act as follows:
“Food additive means any substance the intended use of which results or may reasonably be expected to result, or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown thorough scientific procedures to be safe under the conditions of intended use.”
http://www.fda.gov.ph/BC%202006-016.pdf
Flavours “Flavouring Substances” refer to flavour preparations composed of substances derived from plant/animal products and/or chemically synthesized substances whose significant function in food flavouring rather than nutritional.
AO No. 88-A s.1984, 1
Processing aids “Processing Aids” are additives that are used in the processing of food to achieve a specified technological purpose and which may or may not result in the presence of residues or derivatives in the final product.
AO No. 88-A s.1984, 1
Carry-over Defined in general according to BC 2006-16 FDA Circular No. 2006-016, Part III, C
Related legislation Department of Health Administration Order No. 88-A s.1984 on Regulatory Guidelines Concern Food Additives
Department of Health Food and Drug Administration Circular No. 2006-016 on Updated List of Food Additives
http://www.fda.gov.ph/AO/ao%2088a%20s.%201984.pdf
http://www.fda.gov.ph/BC%202006-016.pdf
Specific Descriptions/Definitions 1 List of Designated Food
Additives Follows Codex GSFA. FDA Circular No. 2006-016, Table 2
2 List of Existing Food Additives
There is no such list in Philippines.
3 List of Plant or Animal sources for Flavouring agents
There is no such list in Philippines.
FDA Circular No. 2006-016, Part VI
4 List of substances which are generally provided for eating or drinking as foods and are used as food additives as well
There is no such list in Philippines
Negative list (if any) Cyclamates, dulcins and p-4000 (5-nitro-2propoxyaniline) are prohibited from use in foods as sweeteners.
Administrative Order No. 122 s.1970 on General Regulation Governing the Prohibition of the Use of Cyclamic Acid and its Salts
Administrative Order No. 125 s. 1970 on General Regulation for Labelling Artificial Sweeteners in the Dietary Management of Disease in Man; Prohibited Artificial Sweeteners
http://www.fda.gov.ph/AO/ao%20122%20s%201970.pdf
http://www.fda.gov.ph/AO/ao%20123%20s.%201970.pdf
Specifications of Food Additives, Weights and Measures, Contaminants, Methods of Analysis and Sampling, Standards of manufacturing of food additives
Follow JECFA specifications. FDA Circular No. 2006-016, Part III, A (5)
Official publication and/or gazette for food additives
There is no official publication and/or gazette for food additives in the Philippines. However, additional food additive and functional classes by Codex are automatically added to the list of additives/ functional classes.
List Usage of food additives in accordance with FDA Circular No. 2006-016 and Codex GSFA. Permitted additives include acidity regulators, antioxidants, colours, flour treatment agents, raising agents and stabilizers. Carry-over of other additives are allowed as approved by FDA and in accordance with Codex principles on carry-over of food additives.
Food additives in Indonesia are defined in Government Regulation No. 28/2004 on
Food Safety, Quality and Nutrition as follows:
“Food additives shall mean any materials added to food in order to affect the nature
and form of the food.”
In the accompanying explanations to the Regulation, it is explained that food
additives do not include contaminants or any materials added into food in order to
maintain or increase the nutritional value of foods. Therefore, substances that may
also nutrients are only considered to be food additives if they have a technological
purpose (for e.g. ascorbic acid as an antioxidant).
The definition of food additives is further defined in subsidiary regulations in
Minister of Health Regulation No. 722/MENKES/PER/IX/88 on Food Additives as
follows:
“Food additive means any substance not normally consumed as a food by itself and
not normally used as a typical ingredient of the food, whether or not it has nutritive
value, the intentional additional of which to food for a technological (including
organoleptic) purpose in the manufacture, processing, preparation, treatment,
packing, packaging, transport or holding of such food results, or may be reasonably
expected to result (direct or indirect) in it or its by-products becoming a component
of or otherwise affecting the characteristics of such foods.”
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Regulation No. 722/MENKES/PER/IX/88 also divides food additives into 11
functional classes in Indonesia, as follows:
1) Antioxidants
2) Anti-caking agents
3) Acidity regulators
4) Artificial sweeteners
5) Flour treatment agents
6) Emulsifiers, stabilizers and thickeners
7) Preservatives
8) Firming agents
9) Colours
10) Flavours and flavour enhancers; and
11) Sequestrants
Processing aids are not defined in the Regulation, however in Government
Regulation No. 28/2004, they are mentioned in reference to genetically modified
food products separately from food additives39.
3.5.4.5.3 Permitted Food Additives and Maximum Limits
The positive list of permitted food additives together with the maximum permitted
use levels are included in the appendixes of Regulation No.
722/MENKES/PER/IX/88 and have been updated once by Regulation No.
1168/MENKES/PER/X/1999.
However, these food additive standards are currently being revised by NADFC and
have/will be issued as national standard by the National Standardization Agency
(BSN). Currently, revised standards for artificial sweeteners (SNI 01-6993-2004,
which has been adopted into regulation as Decision No. HK.00.05.5.1.4547) and
flavours (SNI 01-7152-2006) are already adopted. Draft revisions for antioxidants
and preservatives are being prepared and are expected to be adopted in the near
future.
Although permitted to be used in food in general, such food additives must not
however be used for the following purposes:
1) To mask the use of illegal ingredients or ingredients that are not compliant
with regulations;
39 Article 14 (1) of Government Regulation No. 28/2004 states “Any person who produces food or uses raw
materials, food additives and/or any other processing aid in the activity or process of producing food obtained from genetically modified process shall have the safety of such food examined prior to distribution.”
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2) To mask production practices that are against good manufacturing practices
for food; and
3) To mask the presence of food spoilage.
3.5.4.5.4 Prohibited Substances as Food Additives
A negative list of substances prohibited to be used as food additives are included in
Regulation No. 722/MENKES/PER/IX/88 and Regulation No.
1168/MENKES/PER/X/1999. These include:
1) Boric acid and its derivates;
2) Salicylic Acid and its salts;
3) Diethylpyrocarbonate (DEPC);
4) Dulcin;
5) Potassium chlorate;
6) Chloramphenicol;
7) Brominated vegetable oils;
8) Nitrofurazon;
9) Formaldehyde; and
10) Potassium bromate
In addition, Regulation No. 239/MENKES/PER/V/85 on Colouring Substances that
are Declared to be Hazardous Substances and Decision of the Director-General for
Drug and Food Control No. 00386/C/SK/II/90 on Amendments to the Appendixes of
Regulation No. 239/MENKES/PER/V/85 on Colourings that are Declared to be
Hazardous Substances, also contain negative lists of colouring substances that are
prohibited to be used as food additives.
3.5.4.5.5 Specifications for Food Additives
Food additives that are produced, imported and distributed within the country
must follow the specifications and criteria laid out in the Indonesian Food Codex on
Food Additives (Kodeks Makanan Indonesia). There are currently two editions of
the Indonesian Food Codex, one from 1979 and the other from 2001. Both versions
are still applicable, however the 2001 edition has revised some of the specifications
in the earlier version for certain food additives.
3.5.4.5.6 Assessment of Food Additives
New food additives must first be evaluated and approved by the NADFC prior to
use in food. The assessment procedures and data requirements are described by
Decision of the Director-General for Drug and Food Control No. 02592/B/SK/VIII/91
- 108 -
on Use of Food Additives. Information and data required for the assessment
include:
1) Trade name, type of packaging, manufacturer and manufacturer contact
details for the food additive;
2) Chemical name, composition, specifications or purity criteria, physical and
chemical properties and chemical formula of the food additive;
3) Method of production of the food additive as well as methods of analysis that
are suitable to determine the concentration and purity of the food additive;
4) Purpose and intended use, guidance for use, physical effects, techniques and
methods of use for the food additive, as well as the type of food and maximum
levels intended to be used;
5) Safety evaluation of the food additive and its maximum residue in food
products; and
6) Literature that supports the safety of use of the food additive including
regulation/references that show that the food is also approved for use in
other countries
3.5.4.5.7 Labelling of Food Additives
Labelling of food additives in foods shall be in accordance with existing regulations
on food labelling and advertisement (Government Regulation No. 69/1999 on
Labelling and Advertising of Food). Specifically, the food additive functional class
must be included on the food label. For antioxidants, artificial sweeteners,
preservatives, colours and flavour enhancers, the name of the food additive must
also be included. For colours used as food additive in particular, the special index
numbers also needs to be attached, as specified by Decision of the Director-General
for Drug and Food Control No. 01415/B/SK/IV91 on Special Mark for Food Colours.
Regulation of the head of the Drug and Food Supervisory Agency
HK.03.1.5.12.11.09955 on the registration of processed food was issued on
December 12, 2011. Appendix 3 of this regulation, “Label Requirements of
Processed Food” set several special labelling requirements for several special
processed foods, for example, “Contains Artifitial Sweeteners, recommended not to
be consumed by children, pregnant women, and breastfeeding mothers” for
processed food containing artificial sweeteners.
3.5.4.6 Case Study
(1) Instant Noodles (Table 3.5-13)
Standards for use of food additives in “Instant Noodles (Mi Instan)” (SNI
01-3551-2000) and “instant rice noodles (Bihun instan)” (SNI 01-3742-2000).
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(2) Carbonated Soft Drinks (Table 3.5-14)
Standards for use of food additives in “Lemonade” (SNI 01-2972-1998) , “Diet
lemonade” (SNI 01-3699-1995), “Soda water” (SNI 01-3708-1995) and “Energy
drinks” (SNI 01-6684-2002).
(3) Prepared Frozen Foods (Table 3.5-15)
Standards for use of food additives in “Chicken nugget” (SNI 01-6683-200) and
“Frozen breaded shrimp” (SNI 01-6163-1999).
(4) Cow’s Milk (Table 3.5-16)
Standards for use of food additives in “Pasteurized milk” (SNI 01-3951-1995).
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Table 3.5-A4 Description/Definition (General) Description/Definition Reference Related legislation Minister of Health of the Republic of Indonesia Regulation No.
722/MENKES/PER/IX/88 on Food Additives
SNI 01-7152-2006 Food additives – Flavours - Conditions for use in food products
General Description/Definitions Definition of food
additives The definition of food additives is further defined in subsidiary regulations in Minister of Health Regulation No. 722/MENKES/PER/IX/88 on Food Additives as follows:
“Food additive means any substance not normally consumed as a food by itself and not normally used as a typical ingredient of the food, whether or not it has nutritive value, the intentional additional of which to food for a technological (including organoleptic) purpose in the manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food results, or may be reasonably expected to result (direct or indirect) in it or its by-products becoming a component of or otherwise affecting the characteristics of such foods.”
Regulation No. 722/MENKES/PER/IX/88 Article 1, 1
Flavours “Flavour” is classified under the food additive functional cases of “Flavour and flavour enhancer”, which means substances added to impart or help impart a taste or aroma in food.
“Flavour” means a food additive in the form of concentrate, with or without flavouring adjunct that is used to give flavour, with the exception of salty, sweet and sour taste, that is not intended for direct consumption and not be treated as a food.
Regulation No. 722/MENKES/PER/IX/88 Article 1, 14
SNI 01-7152-2006 Food additives – Flavours - Conditions for use in food products
Processing aids The term “Processing Aid” is mentioned in Government Regulation No. 28/2004 but no definition is provided.
Government Regulation of the Republic of Indonesia No. 28/2004 on Food Safety, Quality and Nutrition, http://www.pom.go.id/public/hukum_perundangan/pdf/PP28-_in%20English_a.pdf
Carry-over “Carry-over” principle is defined for labelling purposes, as follows:
“Carry-over additives are food additives that are normally found in the product formulation as a result of being an ingredient from another ingredient. Examples: Food colouring in orange concentrate; Monosodium glutamate in spices.”
Related legislation Minister of Health of the Republic of Indonesia Regulation No. 722/MENKES/PER/IX/88 on Food Additives Minister of Health of the Republic of Indonesia Regulation No. 1168/MENKES/PER/X/1999 on Amendments to Minister of Health Regulation No. 722/MENKES/PER/IX/88 on Food Additives Decision of the Head of BPOM No. HK.00.05.5.1.4547 on Conditions of Use for Artificial Sweetener Food Additives in Food Products
4 List of substances which are generally provided for eating or drinking as foods and are used as food additives as well
There is no such list in Indonesia.
Negative list (if any) 1) Boric acid and its compounds; 2) Salicylic acid and its salts; 3) Diethylpirocarbonate DEPC; 4) Dulcin; 5) Potassium chlorate; 6) Chloramphenicol; 7) Brominated vegetable oils; 8) Nitrofurazone; 9) Formaldehyde; 10) Potassium bromate
SNI 01-7152-206 Food additives set conditions for use of flavouring materials in food.
Regulation No. 1168/MENKES/PER/X/99 Annex 2 SNI 01-7152-2006 Food additives – Flavours - Conditions for use in food products
Specifications of Food Additives, Weights and Measures, Contaminants, Methods of Analysis and Sampling, Standards of manufacturing of food additives
Indonesian Food Codex 2001 http://www.pom.go.id/public/hukum_perundangan/pdf/Kodeks_MakIndo2001.pdf (not full text)
Official publication and/or gazette for food additives
Apart from regulations issued by the National Agency for Drug and Food Control (NADFC or Badan POM), standards for food additives are also published by the National Standards Body. Currently, up-to-date standards have only been published for two functional classes of additive – flavours and artificial sweeteners.
SNI 01-7152-2006 Food additives – Flavours - Conditions for use in food products SNI 01-6993-2004 Food additives – Artificial sweeteners - Conditions for use in food products
List Flavourings and preservatives are permitted according to existing regulations*.
Use Limitation and/or Maximum Level, if any
* Existing regulations on food additives refer to the following: 1. Minister of Health of the Republic of Indonesia Regulation No. 722/MENKES/PER/IX/88 on Food Additives 2. Minister of Health of the Republic of Indonesia Regulation No. 1168/MENKES/PER/X/1999 on Amendments to Minister of Health Regulation No.
722/MENKES/PER/IX/88 on Food Additives 3. Decision of the Head of BPOM No. HK.00.05.5.1.4547 on Conditions of Use for Artificial Sweetener Food Additives in Food Products
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3.5.5 Thailand
3.5.5.1 Food Administration
In Thailand, the administrative agency responsible for the food safety, food
standards and hygienic control is Ministry of Public Health and Ministry of
Agriculture and Cooperatives.
3.5.5.2 Acts and Regulations related to Commodity Standards
A brief summary of food law in Thailand that relates to the elaboration and
regulation of food commodity standards within the country is presented in Figure
3.5-5 below.
Figure 3.5-5 Food law in Thailand in relation to food commodity standards
3.5.5.3 Food Relevant Laws
(1) Food Act of B.E.2522 (1979)40
In Thailand, the Food Act of B.E.2522 (1979) is the major law aimed at protecting
and preventing consumers from health hazards occurring from food consumption.
According to the Food Act, the Ministry of Public Health (MOPH) is designated to
be in charge of the execution of this Act. The Act also empowered the Ministry of
Public Health to promulgate ministerial regulations, to appoint the Food
40 Food Act of B.E.2522 http://www.thailawforum.com/database1/food-act.html
Related legislation Notification of the Ministry of Public Health No. 281 B.E. 2547 Re: Food Additives
General Description/Definitions Definition of food
additives Food additives are defined in the Notification No. 281 as follows:
“Food additives means articles which normally are not used as food or major ingredients of food, irrespective of their nutritional value, but are added to food for the purpose of manufacturing technology, food colouring, food flavouring, packaging, storage or transportation, which renders certain effects to the quality or standard or description of the food. However, it shall mean to include articles not added to food but are put in a specific container and packed within the food for the above-said purposes as well, such as desiccants, anti-oxidants, etc.”
Flavours Flavouring agents are classified as foods which are required to bear labels. “Flavouring Agents” mean substances used for flavour or taste of food. “Natural Flavouring Agent” means agent for enhancing taste or flavour which is physically derived from plant or animals normally used for human consumption. “Imitate of Natural Flavour Agent” means flavour agent derived from chemical extraction or synthesized flavouring agent in which the extracted substances or synthesized shall be of the same chemical properties as of the natural products normally used for human consumption and shall mean to include imitate of natural flavouring agent which contain natural flavouring agent as well. “Synthesized Flavouring Agent” means flavouring agent which is not discovered in natural products normally used for human consumption and means to include synthesized flavouring agent which contain natural flavour agent or imitate of natural flavouring agent.
Notification of the Ministry of Public Health No. 223 B.E. 2544 (2001) Re: Flavouring Agents
Processing aids “Processing Aid” means substances or any matters which are not for consumption in the manner of food compositions but are used in production of raw materials or food ingredients, by the used technology between qualities adjustment or processing, in which these substances or their derivatives may be unintentionally or inevitable left over, in this regard not to include production equipments.
Notification of the Ministry of Public Health No. 259 B.E. 2545 (2002) Re: Application of Methyl Alcohol as Processing Aid in Some Foods
Negative list (if any) 1) Methyl alcohol or methanol (except for use as a food processing aid); 2) Stevia and stevia products that are non-water crude extractions and/or derivates of substances from crude extraction; 3) Dulcin (para-phenetolcarbamide); 4) Cyclamic acid and its salts (sodium cyclamate); 5) Furylframide; 6) Potassium bromated; 7) Melamine and its analogues (cyanuric acid, ammelide and ammeline); 8) Brominated vegetable oil; 9) Salicylic acid; 10) Boric acid; 11) Borax; 12) Calcium iodate or potassium iodate; 13) Nitrofurazone; 14) Potassium chlorate; 15) Formaldehyde, formaldehyde solution or paraformaldehyde; 16) Coumarin (1,2-benzyopyrone or 5,6-benzo-alpha-pyrone or cis-o-coumaric acid, anhydride or o-hydroxycinnamic acid, lactone); 17) dihydrocoumarin, benzodihydropyrone, 3,4-dihydrocoumarin or hydrocoumarin; 18) diethylene glycol, dihydroxydiethyl ether, diglycol, 2,2’-oxybis-ethanol or 2,2’-oxydiethanol; 19) daminozide or succinic acid 2,2-dimethylhydrazide
http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/1148400006_261-45%281%29.pdf Notification of the Ministry of Public Health No. 292 B.E. 2548 (2005) Re: Prohibited foods to be produced, imported or sold http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/1169705816_no.292.pdf Notification of the Ministry of Public Health No. 311 B.E. 2551 (2008) Re: Prescribed Prohibited Food to be Produced, Imported or Sold http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/1224050701_Notification_No.311_B.E.2551.pdf Notification of the Ministry of Public Health No. 247 B.E. 2544 (2001) Re: Prescribed Prohibited Substances to be Used in Foods (No. 2) http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/1148399024_247-44.pdf Notification of the Ministry of Public Health No. 261 B.E. 2545 (2002) Re: Prescribed Prohibited Food to be Produced, Imported or Sold (No. 2)
Specifications of Food Additives, Weights and Measures, Contaminants, Methods of Analysis and Sampling, Standards of manufacturing of food additives
Mainly follows JECFA and Codex specifications. However, can also be those published by Thai FDA or approved by the Sub-Committee for Studying and Analyzing Problems and Determining Food Technicality.
Notification of the Ministry of Public Health No. 281 B.E. 2547 Re: Food Additives Notification of the Food and Drug Administration of 3rd November B.E. 2547 (2004) Re: Principle of using food additives test methods different from requirements in Codex Advisory Specification for the Identity and Purity of Food Additives http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/1169707498_different%20from%20prescription.pdf
Notification of the Food and Drug Administration of 3rd November B.E. 2547 (2004) Re: Prescription of quality or standards of combined food additives http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/1169707646_food%20add%20cpd.pdf
Notification of the Food and Drug Administration of 17th June B.E. 2548 (2005) Re: Prescription of quality or standards of food additives that are used to prolong or maintain quality or standards of food http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/1169707849_food%20add%20preserv%20type.pdf
Notification of the Food and Drug Administration of 24th June B.E. 2548 (2005) Re: Prescription of quality or standards of single food additives http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/1169710676_single%20food%20additive.pdf
Notification of the Ministry of Public Health (No. 262) B.E. 2545 (2002) Re: Stevioside and Foods Containing Stevioside. http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/1148400098_262-45%281%29.pdf
Official publication and/or gazette for food additives
There is no official publication and/or gazette for food additives. However, updates to food additive regulations are made through issuances of Notifications of the Ministry of Public Health.
Scope and/or Description Semi-processed food in sealed container, including noodle, a sheet of rice noodle (Guay-Jub), wheat noodle, rice vermicelli and mug bean vermicelli
Notification of the Ministry of Public Health No. 210 B.E. 2543 (2000) Re: Semi-processed Food http://www.fda.moph.go.th/eng/eng_food/Notification/210-43.pdf Positive and/or Negative
List Use of food additives are in accordance with Notification of the Ministry of Public Health No. 281 B.E. 2547 Re: Food Additives
Use Limitation and/or Maximum Level, if any
Table 3.5-18 Case Study 2 Carbonated Soft Drinks
Description/Definition Reference
Scope and/or Description Beverage in sealed container Notification of the Ministry of Public Health No. 214 B.E. 2543 (2000) Re: Beverage In Sealed Container http://www.fda.moph.go.th/eng/eng_food/Notification/214-43.pdf
Positive and/or Negative List
Use of artificial sweeteners should follow Codex GSFA and/or as prescribed by the Thai FDA.
Methyl alcohol is prohibited to be used in the production process.
Preservatives including sulfur dioxide, benzoic acid and sorbic acid (including their salts) are permitted.
Use of other additives are in accordance with Notification of the Ministry of Public Health No. 281 B.E. 2547 Re: Food Additives.
Use Limitation and/or Maximum Level, if any
1. Sulfur dioxide: <70mg/kg 2. Benzoic acid (and salts): <200mg/kg 3. Sorbic acid (and salts): <200mg/kg If more than one preservative used together, total quantity of preservatives should not be more than least allowed quantity. When artificial sweeteners are used, the label should state “Usage of […] to be an artificial sweetener” (where […] refers to the artificial sweetener).
There is no standard for use of food additives in “prepared frozen foods” in Thailand.
Table 3.5-19 Case Study 4 Cow’s Milk
Description/Definition Reference
Scope and/or Description Cow’s milk Notification of the Ministry of Public Health No. 265 B.E. 2545 (2002) Re: Cow’s milk http://iodinethailand.fda.moph.go.th/fda/new/images/cms/top_upload/1148400308_265-45%281%29.pdf
Positive and/or Negative List
Preservatives and artificial sweeteners are not permitted.
Use of other additives are in accordance with Notification of the Ministry of Public Health No. 281 B.E. 2547 Re: Food Additives. Use Limitation and/or
Related legislation Law No. 55/2010/QH 12 on Food Safety http://www.vcalaw.com/legal-documents/law-a-ordinance/29-2010lawonfoodsafe/download.html
General Description/Definitions Definition of food
additives Food additives are defined in the Law on Food Safety as follows:
“Food additive means a substance with or without nutritious value, which is intentionally added to food in the process of production in order to retain or improve particular characteristics of food.”
Law No. 55/2010/QH 12 on Food Safety, Article 2 (13)
Flavours Not described
Processing aids “Food Processing Aid” means a substance which is intentionally used in the processing of food materials or food ingredients in order to achieve a technological purpose and can be removed from or remains in foods.
Law No. 55/2010/QH 12 on Food Safety, Article 2 (3)
Carry-over There is no definition of carry over principles in Vietnam.
List Food additive usage in accordance with Codex Standard 249:2006 on Instant Noodles
Use Limitation and/or Maximum Level, if any
Table 3.5-21 Case Study 2 Carbonated Soft Drinks
Description/Definition Reference
Scope and/or Description Soft drinks QCVN 6-2: 2010/BYT National technical regulation for soft drinks Positive and/or Negative
List Food additives usage in accordance with most current regulations –Decision of the Minister of Health No. 3742/2001QD-BYT on List of Additives Permitted for Use in Food Use Limitation and/or
Maximum Level, if any
Case Study 3 Prepared Frozen Foods
There is no food category for “prepared frozen foods” in Vietnam.
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Table 3.5-22 Case Study 4 Cow’s Milk
Description/Definition Reference
Scope and/or Description Fluid milk products QCVN 5-1:2010/BYT National technical regulation for fluid milk products Positive and/or Negative
List Food additives usage in accordance with most current regulations –Decision of the Minister of Health No. 3742/2001QD-BYT on List of Additives Permitted for Use in Food Use Limitation and/or
Maximum Level, if any
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3.6 Overall Report
3.6.1 Comparative Assessment of Regulations on Food Additives in Japan, Korea,
and China
3.6.1.1 Survey Summary
ILSI (International Life Sciences Institute) Japan requested ILSI Korea, ILSI Focal
Point in China, and ILSI Southeast Asia Region to report the current situation about
food additives regulation in each country, and to fill in the questionnaire provided
with the same items so that the comparison among these nations would be easy. ILSI
Japan summarized the reports and questionnaire responses, as well as the situation
in Japan and the Codex General Standard for Food Additives (GSFA), and made
mutual comparison.
The southeast nations in the following report represent six nations we have
surveyed this time: Malaysia, Singapore, Philippines, Indonesia, Thailand, and
Vietnam.
3.6.1.2 Results of Survey in Each Nation
1) Japan
In Japan, food additives include both flavourings and nutrient supplements. It is a
Japanese feature that food additives are extensively defined as the substances used
in food manufacture and processing whether or not they remain in the final food
products.
In 1996, there was a major change in the food additive regulations in Japan.
Previously, only chemically synthesized substances had been controlled by the
positive list system as designated additives; however, both natural and chemically
synthesized additives were placed under the control of positive list system.
Simultaneously, it became obligatory to describe a natural food additive on the label
of the food product in which the additive was used, which had not been required
before. At this change, the food additives which had been already manufactured and
used were shown in the List of Existing Food Additives, and were approved for their
manufacture and use; this list has been updated constantly and some additives were
already eliminated.
Japan has these two positive lists, List of designated Additives and List of Existing
Food additives, both of which are compiled according to the individual names of food
additives. There is no list categorized by function or intended use. Processing aids
and carry-over are not defined under the category of function or use, but are defined
in the requirements when it is not obligatory to describe the food additive on the
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label of the food product in which the additive is used.
In terms of the connection with the Codex standards, Japan might be most remotely
connected compared with China and Southeast Asian nations, where Codex
definitions and annexes are cited and referred to as discussed below. The fact that no
other country has an equivalent of List of Existing Food Additives or List of Food
Additives Generally Provided for Eating or Drinking also highlights Japanese
uniqueness.
2) Korea
In Korea food additives are similarly defined as in Japan, and include the substances
used in the processing but do not remain in the final food products, and nutrient
enhancers. Processing aids and carry-over are similarly stipulated as not obligatory
to be described on the label of the final food product following the regulations for
labelling. However, there is no equivalent of Japanese List of Existing Food
Additives.
Korean Industrial standards (KS) are also similar to Japanese Agricultural
Standards (JAS) in the points that it is voluntary to obtain certification or not, and
that to obtain the certification, the type and amount of food additives which may be
used are limited in certain foods.
3) China
In China, Food Safety Act was established in 2009, based on which the food
sanitation system is under steady development and organization.
Like in Japan and Korea, food additives include both natural and chemically
synthesized substances, as well as flavourings, nutrition enhancers, and processing
aids. Meanwhile, unlike in Japan and Korea, the food additives are numbered; food
category system is stipulated in order to establish the use standards including the
standard maximum use levels of food additives; and the list of food additives, foods
in which the additives are used, and use standards specifying the category of
function and intended use is stipulated. It is likely that these approaches have
consulted the Codex system.
Other Chinese features which are not found in Japan or Korea are that the
processing aids are listed, and that the processing aids which may be used without
limited level of residue are listed, and the processing aids which may be used only in
the designated foods for the designated functions and uses are listed as well.
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3.6.1.3 Comparison of Survey Results on the Food Additives Regulations in Japan,
Korea, and China
Table 3.6-1 tabulates the situation of these three nations.
Nutrition enhancers are excluded from the definitions of food additives in the Codex
standard; but in Japan and Korea, no such description is found in the food additives
definitions, and nutrition enhancers are handled as food additives. In Chinese
definitions of food additives, it is clearly stipulated that the food additives include
nutrition enhancers, flavourings, and processing aids.
In China, there are a list of food categories in which an additive may be used and the
standard maximum use levels for each food additive, a list of food additives which
may be used in all foods in accordance with the Good Manufacturing Practice (GMP),
and a list of food categories as an exemption from these procedures; and these lists
correspond to Table 1, Table 2, and Table 3 in the Annexes of GSFA provisions of food
additives, respectively.
Neither Japan nor Korea has such a system.
3.6.2 Regulation and Harmonization regarding Food Additives in Southeast
Asian Nations
3.6.2.1 Regulation of Food Additives in Southeast Asian Nations
In all the six nations surveyed, the Codex General Standard for Food Additives
(GSFA) was cited unchanged or modified, or utilized in some other forms. Although
the extent and degree of citations and utilizations vary from nation to nation, such
as in definitions, functional and intended use categories, use standards, and/or new
designations/registrations, it is most likely that GSFA would become the common
platform when Southeast Asian nations would aim to harmonize the food additives
regulations in the future.
When we deliberate the harmonization of food additives regulations in Japan, Korea,
China, and Southeast Asian nations, on the basis that China is also trying to actively
utilize GSFA, and that there is little possibility of Japanese system consulted or
cited unchanged in other countries, it is predicted that how Japan would incorporate
Codex system into the Japanese regulation of food additives would be an urgent
task.
3.6.2.2 Comparison of Survey Results on Food Additives Regulation in Southeast
Asian Nations (Table 3.6-2)
In all the six countries surveyed, most or a part of Codex definitions of food additives
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are cited in the food additives definitions. Example are; “whether or not it has
nutritive value,” “in the manufacture, processing, preparation, treatment, packing,
packaging, transport or storage of food,” “intentional addition,” and “be reasonably
expected to result in becoming a component of or otherwise affecting the
characteristics of such foods.”
Although a part of the Codex definitions of flavourings, processing aids, and
carry-over are cited in some countries, compared with the definition of food additives,
these definitions are more varied and different from those of Codex.
There is no equivalent of List of Existing Food Additives or List of Food Additives
Generally Provided for Eating or Drinking found in any nation, including in the
Codex standards.
3.6.2.3 Harmonization of Food Additives Regulation in Southeast Asian Nations
In February 2012, the 10th Workshop on Harmonization of ASEAN Food Safety
Standards was held in Jakarta by ILSI Southeast Asia Regional Office, who has
been working as the organizer since 2001.
Extensive efforts have been made at this workshop such as establishing the
guidelines for risk analysis and organizing the training programs for exposure
assessment by the government employees of Southeast Asian nations in charge of
food safety standards. Among the step-by-step progresses, ASEAN Food Safety
Standards Data Base has accumulated data of 863 food additives so far, promoted by
ILSI Southeast Asia Regional Committee.
In this effort for harmonization, the Codex standards are also utilized so that food
additives are listed according to each category of function and use, and GMP
approach is adopted for the use standards.
However, there are some remaining problems that it is difficult to entry data because
the food categories in the custom code are different from those of GSFA in some
countries, and that the database is not simultaneously and systematically updated
when a country respectively amends its rules.
On December 12, 2011, the regulation of food labelling was revised in Indonesia, and
a certain warning was required on the label of a food where an artificial sweetener
was used (refer pages 92 – 93). Malaysia and Singapore also have regulations of
labelling for certain food additives, but they are different from those in Indonesia.
Meanwhile, Malaysia, Singapore, Philippines, Indonesia, and Thailand have lists of
prohibited food additives, and they are different from country to country. No
equivalent of them can be found in the Codex standards.
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The Codex standards can be a dominant platform for harmonization, but it will not
be an easy task to carry out real harmonization even for the Southeast Asian nations
who utilize the Codex standards.
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General-C-J-K-C
Table 3.6-1 General-C-J-K-CCodex Japan Korea China
Related legislationCODEX STAN 192-1995CAC/GL 66-2008CODEX STAN 107-1981
Food additive means any substance not normally consumed as a food by itselfand not normally used as a typical ingredient of the food, whether or not it hasnutritive value, the intentional addition of which to food for a technological(including organoleptic) purpose in the manufacture, processing, preparation,treatment, packing, packaging, transport or holding of such food results, or maybe reasonably expected to result (directly or indirectly), in it or its byproductsbecoming a component of or otherwise affecting the characteristics of suchfoods. The term does not include contaminants or substances added to food formaintaining or improving nutritional qualities.
“Food additives” means substances to be used in or on food, in theprocess of the manufacturing of food or for the purpose of theprocessing or preserving of food, by adding, mixing, infiltrating, orother means.
Food additives is defined in Article 2.2 of KFSA as “materials added to or mixedwith foods or materials used for wetting foods in the processes ofmanufacturing, processing, or preserving foods. In such cases, food additivesshall include materials used in sterilizing or disinfecting apparatus, containers orpackages, which may be transferred to foods in an indirect manner”.
“Food additives” refer to the artificially or chemically synthetic or naturalsubstances to be added to foods in order to improve food quality andcolour, flavour and taste, and for the need of preservation and processingtechnology, including nutritional fortification substances, flavouring agentsand processing aids.
Flavour
GUIDELINES FOR THE USE OF FLAVOURINGS CAC/GL 66-2008
(ア) Flavour is the sum of those characteristics of any material taken in themouth, perceived principally by the senses of taste and smell, and also thegeneral pain and tactile receptors in the mouth, as received and interpreted bythe brain. The perception of flavour is a property of flavourings.(イ) Flavourings are products that are added to food to impart, modify, orenhance the flavour of food (with the exception of flavour enhancers consideredas food additives under the Codex Class Names and the InternationalNumbering System for Food Additives - CAC/GL 36-1989). Flavourings do notinclude substances that have an exclusively sweet, sour, or salty taste (e.g.sugar, vinegar, and table salt). Flavourings may consist of flavouringsubstances, natural flavouring complexes, thermal process flavourings orsmoke flavourings and mixtures of them and may contain non-flavouring foodingredients (Section 2.3) within the conditions as referred to in 3.5. They are notintended to be consumed as such.
Flavour is classified in the food additive category. “Natural flavouringagent” means food additives, intended for use for flavouring food,which are substances obtained from animals or plants, or mixturesthereof.
Flavourings is recognized as one category of food additives. There is no cleardefinition of “Flavourings” in KFSA, but from its standard of use in KFAC, it isassumed to be defined as “additives used (only) for adding flavourings forfoods”. There are two groups in food additives used for flavourings. One is‘synthetic flavouring substances’ in synthetic additives. All of the permittedchemicals used for flavourings are classified in this group, but there are somesubstances that also appear in KFAC individually with their names becausethey have obligatory specifications. Another group is ‘natural flavouringsubstances’ in natural additives. It is defined as follows and listed by the nameof raw materials. There also be a special limitation in career, extractionsolvents, etc.: “These materials are obtained from the following origins byprocesses such as extraction and distillation. They are used to add or enhancearoma. There are refined oils, extracts, and Oleoresin (spice oleoresin whosespecification is separately set is excluded). Water, ethanol, vegetable oil can beadded for preserving quality”.
The flavouring agents and flavouring essences are used in foods in orderto create, change or improve the flavour of foods. The flavouring agentsare usually made into flavouring essences for flavouring the food, butsome of them may be directly added into the food. The flavouring agentsand flavouring essences exclude the substances which only make thefood sweet, sour or salty and the flavour enhancer. flavours are not usedas a directly consumed ingredient.
Processing aid
CODEX STAN 107-1981
Processing aid means a substance or material not including apparatus orutensils and not consumed as a food ingredient by itself, intentionally used inthe processing of raw materials, foods or its ingredients to fulfil a certaintechnological purpose during treatment or processing and which may result inthe non-intentional but unavoidable presence of residues or derivatives in thefinal product.
Processing aid is classified in the food additive category."Processing aids" means substaces added to a food in processingthe food, which are: 1) removed from the food before the completionof the food, 2) derived from raw materials of the food and convertedinto components normally included in the food but do notsingnificantly increase the amounts of the components, or 3) presentin the finished food at insignificant levels but do not have anytechnical or functional effect of these components onf the food.
There is no clear definition of ‘Processing aids’ in KFSA, but the glossary onKFDA WEB site (only in Korean) defines it as follows: “They are food additivesthat are not specified their function but are used in foods during manufacturingor processing, or used for other purposes. Representatively includes n-Hexane.”
The concept which is similar to its definition in Codex can be found in Article1.A.7) c) (9) of “Detailed labelling Standard”(Attachment 1 to KFLS) as follows:“When a food additive is added during manufacturing but removed from thefinal product, declaration of such additive can be exempted.”
Food processing aids refer to various kinds of substances to enable foodprocessing to go with a swing smoothly, regardless of irrelative to fooditself, for example, nutritional substances for filtration aids, clarificationclarifiers, absorption absorbents, lubrication lubricants, decoating moldrelease agents, decolouring agents, peeling agents, solvents extractionsolvents, and nutritional substances for fermentation, etc. Processingaids are not allowed to remain in the processed food (where they areused) unless other wise specified.
Carry-over
4.1 CONDITIONS APPLYING TO CARRY-OVER OF FOOD ADDITIVESOther than by direct addition, an additive may be present in a food as a result ofcarry-over from a raw material or ingredient used to produce the food, providedthat:
a) The additive is acceptable for use in the raw materials or other ingredients(including food additives) according to this Standard;b) The amount of the additive in the raw materials or other ingredients (includingfood additives) does not exceed the maximum use level specified in thisStandard;c) The food into which the additive is carried over does not contain the additivein greater quantity than would be introduced by the use of raw materials, oringredients under proper technological conditions or manufacturing practice,consistent with the provisions of this standard.
“Carry-over” is defined, but only for labelling purposes."Carry-over" means substances which are used in manufacturing orprocessing raw materials of a food and not used in manufacturing orprocessing the food and which are present in the finished product atlevels less than those normally required to achieve any technical orfunctional effect in the food.
It is not defined in KFAC, but its principle is partially appeared in Article 2. 5. 3)(2) of KFC as follows: “If a food additive that cannot be used in a food is derivedfrom a raw material for which the food additive can be used, the restriction onthe use of food additives may not be applied within the range of such derivingthe raw material.”
Besides direct addition, the food additives can be brought introduced intothe foods through the food ingredients in the following cases;1. The use of the food additive in the food ingredients can only beallowed according to this standard;2. The level of use of this additive in the food ingredients should notexceed the allowable maximum level;3. These ingredients shall be applied in the normal production process.And the content of this additive in the food should not exceed the levelthat is carried over by the ingredients;4. The content of this additive brought introduced into the food by theingredients shall be obviously lower than the usually required level of itthat which is directly added to this the food.
Food additive is listed as “Designated food additives” on theattached table 1 of of the Food Sanitation Act EnforcementRegulations, 1948. There is no classification of function in theselists. As of March 2012, 423 additives are designated asapproved by the MHLW.
As of November 2010 (Notification #2010-82), 602 food additives in total areapproved with the permission to use in respectively designated food groups.Standard and specification of the synthetic additives (400 items), naturaladditives (195 items) and mixed additives (7 items) are listed in the currentKFAC.
The e-book of English version still contains those officially deleted which aresummarized in the appendix 2 (33 synthetic additives and 12 naturaladditives deleted from KFAC).
Flavouring agents of which synthetic ones are covered under the item No424 of synthetic food additives list can be accessed separately in the KFAC.
There is no one list showing all the approved food additives and it ispublished as a notice whenever approved and later they will be listedas new approved addirtives in total as GB3760 or GB14880 is revised.
List of Existing Food Additives
Substances that were already marketed or used on the date ofthe amendment of the FSA in 1995 were listed on the ExistingFood Additives. The MHLW is conducting continuous survey ofmarketing and use of food additives on the list. As of March2012, there are 365 Existing Food Additives in the list.
Not applicable in Korea. Not applicable in China.
List of Plant or Animal sources forFlavouring agents
“List of plant or animal sources of natural flavourings” is given inAppendix 2, the CAA Notice, No. 377, 2010. This list is forlabelling of “Natural flavouring agents” and is NOT a positive listof source of flavouring agents.
Natural Flavourings are categorized as one of Natural additives, and rawmaterials of Natural flavourings are listed in a table of this item in KFAC.The list consists of 272 of each substances and general description “rawmaterials that are appropriate for 2.Requirements for Raw Materials. Common in Food Codes”.
A list of natual flavouring agents is shown in Appendix B.2 of GB2760.
List of substances which are generallyprovided for eating or drinking as foodsand are used as food additives as well
Substances that are both generally provided for eating ordrinking as foods and used as food additives have beenexcluded from the designation system. “List of substanceswhich are generally provided for eating or drinking as foods andwhich are used as food additives” is given in Appendix 3, theCAA Notice, No. 377, 2010.
Not applicable in Korea. Not applicable in China.
Negative list (if any) There is no negative list of food additives under FSA.
In principle, the positive list of food additives are managed under the KoreaFood Sanitation Act. However, for some individual food items (e.g. Instantnoodles, carbonated beverages, etc.), negative list of food additives aredescribed.
There is no negative list of food additives under GB2760
Specifications of Food Additives,Weights and Measures, Contaminants,
Methods of Analysis and Sampling,Standards of manufacturing of food
additives
The last 8th edition is issued in 2007. English translation of 7th
edition, issued in 1999, is available on website.
General provisions of KFAC provides the information of [weight, volume andtemperature], [tests], [container], and [definition of terms].
KFAC main text provides standards for manufacturing and preparation,general standards for food additive used in foods, food contact surfacesanitizing solutions and general test methods as well.
The specifications of food additive, including analytical method, are partof National Food Safety Standards, which should be issued by Ministryof Health. Nevertheless, there are still some food additives that lack ofspecification, and MOH is working on that to cover the gap as soon aspossible.
Official publication and/or gazette forfood additives
Regarding additives for which the specifications and standardshave been established pursuant to the provisions of Article 11,paragraph 1 and additives for which the labelling standardshave been established pursuant to the provisions of Article 19,paragraph 1, the MHLW shall compile the Japanese Standardsof Food Additives to contain such specifications and standards.
Table 3.6-2 General-C-M-S-P-I-Codex Malaysia Singapore Phillipines Indonesia Thailand Vietnam
Related legislationCODEX STAN 192-1995CAC/GL 66-2008CODEX STAN 107-1981
Food Regulations 1985 Food Regulations
Department of Health Administration Order No.88-A s.1984 on Regulatory Guidelines ConcernFood Additives
Department of Health, Food and DrugAdministration Circular No. 2006-016 on UpdatedList of Food Additives
Minister of Health of the Republic of IndonesiaRegulation No. 722/MENKES/PER/IX/88 on FoodAdditives
SNI 01-7152-2006 Food additives – Flavours -Conditions for use in food products
Notification of the Ministry of Public Health No. 281 B.E.2547 Re: Food Additives Law No. 55/2010/QH 12 on Food Safety
General Descriptions /
Definition of Food Additives
CODEX STAN 192-1995
Food additive means any substance not normallyconsumed as a food by itself and not normally used as atypical ingredient of the food, whether or not it has nutritivevalue, the intentional addition of which to food for atechnological (including organoleptic) purpose in themanufacture, processing, preparation, treatment, packing,packaging, transport or holding of such food results, or maybe reasonably expected to result (directly or indirectly), in itor its byproducts becoming a component of or otherwiseaffecting the characteristics of such foods. The term doesnot include contaminants or substances added to food formaintaining or improving nutritional qualities.
Food additives are defined in the Food Regulations asfollows:“Food additive means any safe substance that isintentionally introduced into or on a food in smallquantities in order to affect the food’s keeping quality,texture, consistency, appearance, odour, taste,alkalinity, or acidity, or to serve any other technologicalfunction in the manufacture, processing, preparation,treatment, packing, packaging, transport, or storage ofthe food, and that results or may be reasonablyexpected to result directly or indirectly in the substanceor any of its by-products becoming a component of, orotherwise affecting the characteristics of, the food, andincludes any preservative, colouring substance,flavouring substance, flavour enhancer, antioxidantand food conditioner, but shall not include addednutrient, incidental constituent or salt.”
“Food additive includes –i) all substances, which are components of food,the intended use of which results or mayreasonably be expected to result, directly orindirectly, in their affecting the characteristics offood but does not include any foreign substancemixed with food as a result of contamination, orimproper handling of the food during thepreparation, processing, packing or storage of thefood; andii) anti-caking agents, anti-foaming agents, anti-oxidants, sweetening agents, chemicalpreservatives, colouring matters, emulsifiers orstabilizers, flavouring agents, flavour enhancers,humectants, nutrient supplements, sequestrantsand other general purpose food additives.”
Food additives are defined in the Food, Drug andCosmetic Act as follows:“Food additive means any substance the intendeduse of which results or may reasonably beexpected to result, or indirectly, in its becoming acomponent or otherwise affecting thecharacteristics of any food (including anysubstance intended for use in producing,manufacturing, packing, processing, preparing,treating, packaging, transporting, or holding food;and including any source of radiation intended forany such use), if such substance is generallyrecognized, among experts qualified by scientifictraining and experience to evaluate its safety, ashaving been adequately shown thorough scientificprocedures to be safe under the conditions ofintended use.”
The definition of food additives is further definedin subsidiary regulations in Minister of HealthRegulation No. 722/MENKES/PER/IX/88 on FoodAdditives as follows:“Food additive means any substance not normallyconsumed as a food by itself and not normallyused as a typical ingredient of the food, whetheror not it has nutritive value, the intentionaladditional of which to food for a technological(including organoleptic) purpose in themanufacture, processing, preparation, treatment,packing, packaging, transport or holding of suchfood results, or may be reasonably expected toresult (direct or indirect) in it or its by-productsbecoming a component of or otherwise affectingthe characteristics of such foods.”
Food additives are defined in the Notification No. 281as follows:“Food additives means articles which normally are notused as food or major ingredients of food, irrespectiveof their nutritional value, but are added to food for thepurpose of manufacturing technology, food colouring,food flavouring, packaging, storage or transportation,which renders certain effects to the quality or standardor description of the food. However, it shall mean toinclude articles not added to food but are put in aspecific container and packed within the food for theabove-said purposes as well, such as desiccants, anti-oxidants, etc.”
Food additives are defined in the Law on FoodSafety as follows:“Food additive means a substance with or withoutnutritious value, which is intentionally added tofood in the process of production in order to retainor improve particular characteristics of food.”
Flavour
GUIDELINES FOR THE USE OF FLAVOURINGS CAC/GL66-2008
(ア) Flavour is the sum of those characteristics of anymaterial taken in the mouth, perceived principally by thesenses of taste and smell, and also the general pain andtactile receptors in the mouth, as received and interpretedby the brain. The perception of flavour is a property offlavourings.(イ) Flavourings are products that are added to food toimpart, modify, or enhance the flavour of food (with theexception of flavour enhancers considered as foodadditives under the Codex Class Names and theInternational Numbering System for Food Additives -CAC/GL 36-1989). Flavourings do not include substancesthat have an exclusively sweet, sour, or salty taste (e.g.sugar, vinegar, and table salt). Flavourings may consist offlavouring substances, natural flavouring complexes,thermal process flavourings or smoke flavourings andmixtures of them and may contain non-flavouring foodingredients (Section 2.3) within the conditions as referred toin 3.5. They are not intended to be consumed as such.
“Flavouring substance” means any substance that,when added to food, is capable of imparting flavour tothat food and includes spices specified in regulation286 to 333.
“Natural Flavouring Substance” means any flavouringsubstance obtained exclusively by physical processesfrom vegetable, fruit or animal, either in their naturalstate or processed, for human consumption.
“Nature Identical Flavouring Substance” means anyflavouring substance chemically isolated from aromaticraw materials or obtained synthetically, and arechemically identical to substances present in naturalproducts intended for human consumption, eitherprocessed or not.
“Flavour Agent” means any wholesomesubstance that when added or applied to food iscapable of imparting taste or odour, or both, to afood.
“Natural Flavouring Agents” shall include naturalflavouring essences, spices and condiments.
“Synthetic Flavouring Essences or Extracts” shallinclude any artificial flavour or imitation flavourwhich may resemble the sapid or odoriferousprinciples of an aromatic plant, fruit or vegetableor any other food, except that the flavouringprinciple shall be derived in whole, or in part, fromeither chemical synthesis or any other sourcesthat does not involve extraction or isolationtherefrom of the sapid or odoriferous principlespresent in an aromatic plant, fruit or vegetable orany other food.
“Flavouring Substances” refer to flavourpreparations composed of substances derivedfrom plant/animal products and/or chemicallysynthesized substances whose significantfunction in food flavouring rather than nutritional.
“Flavour” is classified under the food additivefunctional cass of “Flavour and flavour enhancer”,which means substances added to impart or helpimpart a taste or aroma in food.
“Flavour” means a food additive in the form ofconcentrate, with or without flavouring adjunctthat is used to give flavour, with the exception ofsalty, sweet and sour taste, that is not intendedfor direct consumption and not be treated as afood.
Flavouring agents are classified as foods which arerequired to bear labels. “Flavouring Agents” meansubstances used for flavour or taste of food.
“Natural Flavouring Agent” means agent for enhancingtaste or flavour which is physically derived from plant oranimals normally used for human consumption.
“Imitate of Natural Flavour Agent” means flavour agentderived from chemical extraction or synthesizedflavouring agent in which the extracted substances orsynthesized shall be of the same chemical propertiesas of the natural products normally used for humanconsumption and shall mean to include imitate ofnatural flavouring agent which contain natural flavouringagent as well.
“Synthesized Flavouring Agent” means flavouring agentwhich is not discovered in natural products normallyused for human consumption and means to includesynthesized flavouring agent which contain naturalflavour agent or imitate of natural flavouring agent.
Not described
Processing aid
CODEX STAN 107-1981
Processing aid means a substance or material notincluding apparatus or utensils and not consumed as afood ingredient by itself, intentionally used in the processingof raw materials, foods or its ingredients to fulfil a certaintechnological purpose during treatment or processing andwhich may result in the non-intentional but unavoidablepresence of residues or derivatives in the final product.
Processing aids are considered as food additivesunder the functional class of “food conditioner”.
“Processing Aids” are considered as “GeneralPurpose Food Additives”, which means anysubstance which serves a useful and specificpurpose during either the processing or packingof a food and shall include processing aid.
“Processing Aids” are additives that are used inthe processing of food to achieve a specifiedtechnological purpose and which may or may notresult in the presence of residues or derivatives inthe final product.
The term “Processing Aid” is mentioned inGovernment Regulation No. 28/2004 but nodefinition is provided.
“Processing Aid” means substances or any matterswhich are not for consumption in the manner of foodcompositions but are used in production of rawmaterials or food ingredients, by the used technologybetween qualities adjustment or processing, in whichthese substances or their derivatives may beunintentionally or inevitable left over, in this regard notto include production equipments.
“Food Processing Aid” means a substance whichis intentionally used in the processing of foodmaterials or food ingredients in order to achieve atechnological purpose and can be removed fromor remains in foods.
Carry-over
4.1 CONDITIONS APPLYING TO CARRY-OVER OFFOOD ADDITIVESOther than by direct addition, an additive may be present ina food as a result of carry-over from a raw material oringredient used to produce the food, provided that:
a) The additive is acceptable for use in the raw materials orother ingredients (including food additives) according to thisStandard;b) The amount of the additive in the raw materials or otheringredients (including food additives) does not exceed themaximum use level specified in this Standard;c) The food into which the additive is carried over does notcontain the additive in greater quantity than would beintroduced by the use of raw materials, or ingredients underproper technological conditions or manufacturing practice,consistent with the provisions of this standard.
“Carry-over” principle is described in general in theFood Regulations, with restricted list of additivesallowed to be carried over for infant formula.
Food ingredients that are added to foods mayalso contain food additives for the types ofadditives permitted and in accordance with thelevels specified for the food ingredients.
Defined in general according to BC 2006-16
“Carry-over” principle is defined for labellingpurposes, as follows:“Carry-over additives are food additives that arenormally found in the product formulation as aresult of being an ingredient from anotheringredient. Examples: Food colouring in orangeconcentrate; Monosodium glutamate in spices.”
There is no definition of carry over principles inThailand.
There is no definition of carry over principles inVietnam.
General-C-M-S-P-I-T-V
Specific-M-S-P-I-T-V
Table 3.6-2 Specific-M-S-P-I-T-VMalaysia Singapore Phillipines Indonesia Thailand Vietnam
Related legislation Food Regulations 1985 Food Regulations
Department of Health Administration Order No. 88-As.1984 on Regulatory Guidelines Concern FoodAdditives
Department of Health Food and Drug AdministrationCircular No. 2006-016 on Updated List of Food Additives
Minister of Health of the Republic of IndonesiaRegulation No. 722/MENKES/PER/IX/88 on FoodAdditives
Minister of Health of the Republic of IndonesiaRegulation No. 1168/MENKES/PER/X/1999 onAmendments to Minister of Health Regulation No.722/MENKES/PER/IX/88 on Food Additives
Decision of the Head of BPOM No. HK.00.05.5.1.4547on Conditions of Use for Artificial Sweetener FoodAdditives in Food Products
Notification of the Ministry of Public Health No. 281 B.E.2547 Re: Food Additives
Decision of the Minister of Health No. 3742/2001QD-BYT on List of Additives Permitted for Use in Food
Specific descriptions / Additionalexplanations
List of Designated Food AdditivesIncludes preservative, antimicrobial agent,colouring substance, flavouring substance,flavour enhancer, antioxidant, antioxidant andfood conditioner.
List of Existing Food Additives There is no such list in Malaysia. There is no such list in Singapore. There is no such list in Philippines. There is no such list in Indonesia. There is no such list in Thailand. There is no such list in Vietnam.
List of Plant or Animal sources forFlavouring agents
There is no such list in Malaysia. There is no such list in Singapore. There is no such list in Philippines. There is no such list in Indonesia. There is no such list in Thailand. There is no such list in Vietnam.
List of substances which are generallyprovided for eating or drinking as foodsand are used as food additives as well
There is no such list in Malaysia. There is no such list in Singapore. There is no such list in Philippines. There is no such list in Indonesia. There is no such list in Thailand. There is no such list in Vietnam.
Negative list (if any) There is a list of flavouring substances the useof which is prohibited or limited in Malayasia.
There is a list of prohibited substances for use asflavouring agents.
Cyclamates, dulcins and p-4000 (5-nitro-2propoxyaniline) are prohibited from use in foods assweeteners.
Administrative Order No. 122 s.1970 on GeneralRegulation Governing the Prohibition of the Use ofCyclamic Acid and its Salts
Administrative Order No. 125 s. 1970 on GeneralRegulation for Labelling Artificial Sweeteners in theDietary Management of Disease in Man; ProhibitedArtificial Sweeteners
1) Boric acid and its compounds; 2) Salicylic acid and itssalts; 3) Diethylpirocarbonate DEPC; 4) Dulcin; 5)Potassium chlorate; 6) Chloramphenicol; 7) Brominatedvegetable oils; 8) Nitrofurazone; 9) Formaldehyde; 10)Potassium bromate
SNI 01-7152-206 Food additives set conditions for useof flavourig materials in food.
1) Methyl alcohol or methanol (except for use as a foodprocessing aid); 2) Stevia and stevia products that arenon-water crude extractions and/or derivates ofsubstances from crude extraction; 3) Duclin (para-phenetolcarbamide); 4) Cyclamic acid and its salts(sodium cyclamate); 5) Furylframide; 6) Potassiumbromated; 7) Melamine and its analogues (cyanuric acid,ammelide and ammeline); 8) Brominated vegetable oil;9) Salicylic acid; 10) Boric acid; 11) Borax; 12) Calciumiodate or potassium iodate; 13) Nitrofurazone; 14)Potassium chlorate; 15) Formaldehyde, formaldehydesolution or paraformaldehyde; 16) Coumarin (1,2-benzyopyrone or 5,6-benzo-alpha-pyrone or cis-o-coumaric acid, anhydride or o-hydroxycinnamic acid,lactone); 17) dihydrocoumarin, benzodihydropyrone, 3,4-dihydrocoumarin or hydrocoumarin; 18) diethyleneglycol, dihydroxydiethyl ether, diglycol, 2,2’-oxybis-ethanol or 2,2’-oxydiethanol; 19) daminozide or succinicacid 2,2-dimethylhydrazide
There is no negative list of food additives in Vietnam.
Specifications of Food Additives, Weightsand Measures, Contaminants, Methods of
Analysis and Sampling, Standards ofmanufacturing of food additives
Found in Malaysian Standard 1282 Parts 1-8for acidity regulator; preservative; antioxidant;flavour enhancer; stabilizer, thickener andgelling agent; solvent; anticaking agent; andcolouring substance.
Follows JECFA specifications. Follow JECFA specifications. Indonesian Food Codex 2001
Mainly follows JECFA and Codex specifications.However, can also be those published by Thai FDA orapproved by the Sub-Committee for Studying andAnalyzing Problems and Determining Food Technicality.
Official publication and/or gazette for foodadditives
No official publication and/or gazette for foodadditives. However, updates on food additivesare announced on the FSQD, MOH, Malaysiawebsite.
There is no official publication and/or gazette forfood additives. However, official circulars areissued when food regulations are amended.
There is no official publication and/or gazette for foodadditives in the Philippines. However, additional foodadditive and functional classes by Codex areautomatically added to the list of additives/ functionalclasses.
Apart from regulations issued by the National Agency forDrug and Food Control (NADFC or Badan POM),standards for food additives are also published by theNational Standards Body. Currently, up-to-datestandards have only been published for two functionalclasses of additive – flavours and artificial sweeteners.
There is no official publication and/or gazette for foodadditives. However, updates to food additive regulationsare made through issuances of Notifications of theMinistry of Public Health.
There is no official publication or gazette for foodadditives in Vietnam.
Specific-M-S-P-I-T-V
Case J-K-C
China
Food Sanitation Act JAS Law (voluntary standards) Food Sanitation Act KS (voluntary standards) Food Categories in GB2760
1. Instant Noodles
Standards for “Instant Noodles” is defined inFood Sanitation Act, but it only includesspecification and standards of storage for oil-processed type Noodles. Limitation of use ofsome food additives to Instant Noodles(including their attached soup powder) aredefined at JSFA.
Positive List (limitation in use)
Specification of noodles are described in Korea Food Code.
Positive /negative list of food additives for noodles should becomplied in Korea.
Below food additives should not be detected in the products :- Prepared Tar Dyes (colour)- Preservatives- Titanium dioxide
Sodium Stearoyl Lactylate is permitted for use in noodles.
Fried Noodles (KS H 2508), Dried Noodles (KSH 2505), Raw Noodles (KS H 2506), andCooked Noodles (KS H 2507)
Noodles were specified as fried noodles andnon-fried noodles.
Tar colour should not be detected.
06.0 Cereals and cereal products06.03 Wheat flour and its product06.03.01 Wheat flour06.03.01.01 All-purpose wheat flour06.03.02 Wheat flour product06.07 Pre-cooked (instant) noodles and rice
2. Carbonated SoftDrinks
Maximum level of several food additives in“non-alcoholic beverage” is set in “theStandards for use of Food Additives ”
Standards of soft drinks are described in FSA.
But no positive/negative list on food additives init.
In “the Standards for use of Food Additives”,maximum level of several food additives in“non-alcoholic beverage” is set and some foodadditives are prohibited to be used in “non-alcoholic beverages”.
-Preservatives: only sodium benzoate and p-hydroxybenzoic acid allowed
-Antioxidants: only L-ascorbic acid and sodiumL-ascorbate allowed
Specification of carbonated beverages are described in KoreaFood Code- Carbonated beverages, Carbonated water.
Positive/negative list on food additives (Korea Food AdditivesCode).
Some food additives are allowed to use in carbonatedbeverages and maximum levels in soft drinks are set as below:- Preservatives: Benzoic acid, sodium benzoate, potassiumbenzoate, and calcium benzoate less than 0.6g/kg are permittedto only carbonated beverages (excluding carbonated water).- Ester Gum less than 0.1/kg- Manganese gluconate (no maximum level specified)
Some food additives are not allowed to use in carbonatedbeverages:-Food Red No.2-Food Red No. 2 Aluminum Lake.
Carbonated soft drinks
No positive/negative list included. It isrecommended to follow the Korea Food Code.
14.0 Beverage14.04 Water-based flavoured beverage14.04.01 Carbonated drink14.04.01.01 Cola type carbonated drink14.04.01.02 Other carbonated drink
3. Prepared FrozenFoods
Specifications of prepared frozen foods aredescribed in FSA.
No positive/negative list on food additives in it.
The restrictions in use of food additives areapplied to the foods to be frozen, not to thefrozen foods.
Positive List (limitation in use)
Food additive standards for frozen food should comply to thosefor respective food item as designated in the Korea Food Codeand/or Food Additive Code.
“Frozen food” means a food made by filling the manufactured,processed, cooked food into container and packaging materialsafter freezing treatment for the purpose of long-term storage.(1) Frozen food not requiring heat process before consumption:Frozen food that can be consumed without a separate heatingprocess.(2) Frozen food requiring heating process before consumption:Frozen food that can be consumed only after a separate heatingprocess.
Frozen prepared dumplings (KS H 4001),Frozen prepared croquet (KS H 4002), Frozenbattered Shrimps (KS H 4003), Frozen FriedPork (KS H 4004), and Frozen Fried Fish (KS H6032)
No positive/negative List is included. Generally,it should comply the Korea Food Code and/orFood Additive Code.
06.0 Cereals and cereal products06.03 Wheat flour and its product06.03.01 Wheat flour06.03.01.01 All-purpose wheat flour06.03.01.02 Special wheat flour06.03.02 Wheat flour product06.03.02.01 Fresh pasta06.08 Frozen rice and flour product06.1 Filling for grain product
4. Cow’s Milk Use of food additives in milk is prohibited orrestricted by FSA No JAS Mark standard for Cow’s Milk
Milk is defined as the milk pasteurized or sterilized.
Use of food additives in milk is prohibited or restricted under theKorea FSA.
(Sanitary control for livestock products has designated milks formilk, fortified milk, reconstituted milk, and lactic acid bacteriaadded milk.)
There is no positive/negative list in KS.
Milk was included in the milks (KS H 2195) inKS.
01.0 Milk and dairy product01.01 Pasteurized milk, sterilized milk and recombined milk01.01.01 Pasteurized milk01.01.02 Sterilized milk
Japan KoreaCase Study Foods
Case M-S-P-I-T-V
Case Study Foods Malaysia Singapore Phillipines Indonesia Thailand Vietnam
1. Instant Noodles
PastaShould not contain any prohibited flavouring substances under the Food Regulations 1985.May contain Transglutaminase and sulphur dioxide or sulphites, as permitted food conditioner at< 200mg/kg.
Instant wheat noodlesFood additives are permitted in accordance with Food Regulations 1985.
Instant rice noodlesPreservatives are prohibited.Other additives are permitted in accordance with Food Regulations 1985.
PastaPermitted flavouring agents and colouring matters according to FoodRegulations.
Dried noodles and pasta productsNot specified.
Flour sticks (pancit canton)Usage of food additives in accordance with FDA Circular No. 2006-016 and CodexGSFA.
Permitted additives include acidity regulators, antioxidants, colours, flour treatmentagents, raising agents and stabilizers.
Carry-over of other additives are allowed as approved by FDA and in accordancewith Codex principles on carry-over of food additives.1. Sodium hydroxide: GMP2. Butylated hydroxyanisole (BHA): <100mg/kg3. Butylated hydroxytoluene (BHT): <200mg/kg4. Tocopherol: GMP5. Tartrazine: <300mg/kg6. Sunset Yellow: <300mg/kg7. Phosphates (as sodium or potassium phosphates): <2,200mg/kg8. Sodium carbonate: <2,600mg/kg9. Potassium carbonate: <2,600mg/kg
Instant noodlesFood additives are permitted in accordance to existingregulations*.
Instant rice noodlesFood additives are permitted in accordance to existingregulations*.
Semi-processed food in sealed container, including noodle,a sheet of rice noodle (Guay-Jub), wheat noodle, ricevermicelli and mug bean vermicelli
Use of food additives are in accordance with Notification ofthe Ministry of Public Health No. 281 B.E. 2547 Re: FoodAdditives
Instant noodlesFood additive usage in accordance with CodexStandard 249:2006 on Instant Noodles
2. Carbonated SoftDrinks
Flavoured drinkShould not contain any prohibited flavouring substances under the Food Regulations 1985.May contain permitted preservative, colouring substance and food conditioner in accordancewith Food Regulations 1985.1. Ester gum: <150mg/l2. β-cyclodextrin: <150mg/l3. Caffeine-containing plant extract as flavouring substance: <200mg/l4. Sulphur dioixde: <140mg/l5. Benzoic acid: <350mg/kg6. Agaric acid: <20mg/kg7. Total hydrocyanic acid (free and combined): <1mg/kg8. Pulegone: <100mg/kg (except peppermint or mint flavoured beverages) or 250mg/kg (forpeppermint or mint flavoured beverages)9. Quassin: <5mg/kg10. Quinine: <85mg/kg11. Thujones: <0.5mg/kg
Ready-to-drink beveragesPermitted acidity regulators: citric acid, phosphoric acid, lactic acid, malic acid, acetic acid,fumaric acid, tartaric acid (including the sodium, potassium and calcium salts)Permitted colours, nutritive and non-nutritive sweeteners in accordance with Food Regulations1985.Permitted mineral salts: sodium carbonate and sodium bicarbonatePermitted preservatives and flavouring agents1. Sulphuric acid: <140ppm2. Benzoic acid: <350ppm3. Sorbic acid: <350ppm4. Caffeine: <150ppm5. Quinine: 40-85ppm6. Ascorbic acid: 10mg/100ml
Citrus beverage productsUsage of food additives in accordance with FDA Circular No. 2006-016 and CodexGSFA.
Permitted additives include:1. acidity regulator (citric acid, malic acid, calcium carbonate, adipates)2. anticaking agent (calcium aluminium silicate – synthetic, microcrystallinecellulose; aluminium silicate, carnauba wax)3. antioxidant (ascorbic acid, calcium ascorbate, erythorbic acid, potassiumascorbate, sodium ascorbate, sodium erythorbate)4. colour (carotenoids, chlorophylls, chlorophyll copper complexes, sulphites,carbon dioxide, phosphates, ethylenediaminetetraacetic acid/EDTA)5. stabilizer/thickener (calcium chloride, carob bean gum, carrageenan, gellan gum,guar gum, gum arabic, karaya gum, lactic and fatty acid esters of glycerol, pectins,potassium alginate, sodium alginate, tara gum, tragacanth gum, xanthan gum,agar, konjac flour, sodium carboxymethylcellulose6. sweetener (acesulfame potassium, aspartame, saccharin, sucralose)7. Processing aids (antifoaming agents:- polydimethylsiloxane; clarifyingagents/filtration aids/flocculating agents :- adsorbent clays, adsorbent resins,activated carbon – only from plants, bentonite, cellulose, chitosan, colloidal silica,diatomaceous earth, gelatin – from skin collagen, ion exchange resin – cation andanion, kaolin, perlite; enzyme preparations:- pectinases – for breakdown of pectin,proteinases – for breakdown of proteins, amylases – for breakdown of starch,cellulases – limited use to facilitate disruption of cell walls; packaging gas:-nitrogen, carbon dioxide
LemonadeArtificial sweeteners (e.g. cyclamates and saccharin) areprohibited.
Colours and preservatives are permitted in accordance to existingregulations*.
Diet lemonadeFood additives are permitted in accordance to existingregulations*.
Soda waterFood additives are not allowed except for mineral salts inaccordance to existing regulations*.
Energy drinksFood additives are permitted in accordance to existingregulations*.
Beverage in sealed containerUse of artificial sweeteners should follow Codex GSFAand/or as prescribed by the Thai FDA. Methyl alcohol is prohibited to be used in the productionprocess.
Preservatives including sulfur dioxide, benzoic acid andsorbic acid (including their salts) are permitted.
Use of other additives are in accordance with Notification ofthe Ministry of Public Health No. 281 B.E. 2547 Re: FoodAdditives.
If more than one preservative used together, total quantityof preservatives should not be more than least allowedquantity.
When artificial sweeteners are used, the label should state“Usage of […] to be an artificial sweetener” (where […]refers to the artificial sweetener).
Soft drinksFood additives usage in accordance with mostcurrent regulations –Decision of the Minister ofHealth No. 3742/2001QD-BYT on List of AdditivesPermitted for Use in Food
3. Prepared FrozenFoods
Meat frankfurtersFood additives are permitted in accordance with Food Regulations 1985.
Meat burgersFood additives are permitted in accordance with Food Regulations 1985.
There is no food category for “prepared frozen foods” in Singapore. There is no food category for “prepared frozen foods” in the Philippines.
Chicken nuggetPreservatives and colours are permitted in accordance to existingregulations*.
Frozen breaded shrimpFood additives used should not impair or change the compositionand specific properties of the frozen breaded shrimp.Food additives are permitted in accordance to existingregulations*.
There is no standard for use of food additives in “preparedfrozen foods” in Thailand.
There is no food category for “prepared frozenfoods” in Vietnam.
4. Cow’s Milk Milk, raw milk or fresh milkFood additives are prohibited according to Food Regulations 1985.
MilkFood additives are prohibited according to Food Regulations.
Fresh milkUsage of food additives in accordance with FDA Circular No.2006-016 and CodexGSFA.
Pasteurized milkFlavourings and preservatives are permitted according to existingregulations*.
Cow’s milkPreservatives and artificial sweeteners are not permitted.Use of other additives are in accordance with Notification ofthe Ministry of Public Health No. 281 B.E. 2547 Re: FoodAdditives.
Fluid milk productsFood additives usage in accordance with mostcurrent regulations –Decision of the Minister ofHealth No. 3742/2001QD-BYT on List of AdditivesPermitted for Use in Food
* Existing regulations on food additives refer to the following:1. Minister of Health of the Republic of Indonesia Regulation No. 722/MENKES/PER/IX/88 on Food Additives2. Minister of Health of the Republic of Indonesia Regulation No. 1168/MENKES/PER/X/1999 on Amendments to Minister ofHealth Regulation No. 722/MENKES/PER/IX/88 on Food Additives3. Decision of the Head of BPOM No. HK.00.05.5.1.4547 on Conditions of Use for Artificial Sweetener Food Additives in FoodProducts
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4. India
4.1 Preliminary Investigation on Indian Food Related Laws
Preliminary investigation was conducted on Indian food regulatory organizations
and food laws, prior to the investigation on food standards and analysis methods.
4.2 Transition from the Old Food Legal Structures to the New Food Legal
Structures
Indian food related laws consisted of Prevention of Food Adulteration Act, 1954 and
Rules, 1955 which was established in 1954 and had been supervised by Ministry of
Health & Family Welfare, and many other food related laws which were supervised
by other multiple ministries and agencies (Figure 4-1).
Prevention of Food Adulteration Act and Rules had undergone repeated
amendments since 1954, and there were many unclear points to interpret in the Act
and Rules. Also there were many problems such as complexity resulted from
supervision of many foods related laws by multiple ministries and agencies and
inconsistency with international standards such as Codex. Thus since 2004 or so,
movements toward the integration of such complicated food related legal structures
and the transition to the food safety-based integrated food law based on
international harmonization and risk analysis have started.
In January 2005, Food Safety and Standards Bill, which was the origin of the
existing Food Safety and Standards Act, 2006, was proposed by Ministry of Food
Processing Industries. This bill covered the following chapters: The establishment
of Food Safety and Standards Authority of India (FSSAI) which was the new
authority in charge of all food administrations, the establishment of Central
Advisory Committee, the establishment of Scientific Committee and Scientific
Panel as the organization for the risk assessment, general principles for food safety,
basic regulations for food additives, contaminants, agrichemicals, labelling,
genetically modified foods, organic foods, functional foods and advertisements,
responsibilities of food producers, basic regulation for food analysis and
implementation, basic regulation of imports and exports, rules of violations and
penalties, regulations regarding adjudication and suits, regulations regarding
finance and audit reports, and others. Also, the revision or repeal and integration of
15 laws including Prevention of Food Adulteration Act, 1954 and Rules, 1955 were
described.
This bill was approved among ministers of related ministries in April, 2005. Then,
there was jockeying between Ministry of Food Processing Industries which created
the bill and Ministry of Health & Family Welfare which had jurisdiction over
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Prevention of Food Adulteration Act and Rules. But finally Ministry of Health &
Family Welfare became competent authority. After the revisions, Food Safety and
Standard Act, 2006 came into force in August, 2006.
In 2009, draft Food Safety and Standards Rules & Regulation, which were detailed
regulations of Food Safety and Standards Act, 2006, were announced and public
comments were invited. However, new detailed regulations of Food Safety and
Standards took over almost all the contents of the old Prevention of Food
Adulteration Act and Rules only with the change of the composition. Thus,
international harmonization, which was one of the purposes, was not achieved.
After the revision in 2010, the draft Rules came into force in May, 2011 and the
draft Regulations came into force in August, 2011, respectively (Figure 4-1).
For regulations for food additives, concept notes in which a positive list based on
Codex was introduced for the purpose of harmonization with Codex and public
comments were invited. Draft regulations for functional foods and for imported
foods were announced and public comments were invited. Now the work for revision
is ongoing.
Indian Food Regulations
Bureau of Indian Standards Certification Mark (ISI) for milk products, infant formula, packaged water etc. is mandatory under FSS regulation
Food Safety and Standard Act, 2006 Food Safety and Standard Regulations, 2011
(Food product standards and food additives)(Packaging and labelling)
(Prohibition and restriction on sales) (Contaminants, toxins and residues) (Laboratory and sampling analysis)
(Licensing and registration of food businesses)Milk and Milk Products Regulation, 2011
Food Safety and Standard Rules, 2011
Standards of Weights and Measures Act, 1976
The Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992
Atomic Energy (Control of Irradiation of Food) Rules, 1991
The Insecticide Act, 1968
Orders under Essential Commodities Act, 1955 relating to food